National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
March 23, 2010 • Volume 7 / Number 6

Page Options

  • Print This Document
  • Email This Document

NEWS

I-SPY2 trial logoI-SPY2: Breast Cancer Trial Aims to Speed Drugs to the Clinic

On March 17, the Foundation for the National Institutes of Health and its Biomarkers Consortium announced the launch of the I-SPY2 breast cancer clinical trial, a novel, adaptive clinical study designed to move promising new drugs into phase III clinical trials more quickly and cost effectively than traditional phase II studies. Read more > >

COMMENTARY

Drs. Ann O’Mara and Andrea DenicoffGuest Director's Update: Improving Delivery of Quality Cancer Care

by Dr. Ann O’Mara and Andrea Denicoff

During a recent meeting with NCI-funded investigators at Memorial Sloan-Kettering Cancer Center in New York, we saw an older gentleman sitting in the waiting room, his wife by his side, with a small tablet PC on his lap. He was, we learned, completing a questionnaire about any symptoms or side effects he was having from the treatment he was undergoing for metastatic prostate cancer. Read more > >

Guest Commentary by Dr. Andrea Barsevick: Fatigue—Is it Normal or Pathological? And How Can We Best Treat It?

Soon experts will meet to discuss state of the science and how research can move forward more efficiently Read more > >

A Conversation with Dr. Ann Berger on Palliative Care at NIH

The head of the Pain and Palliative Care Service talks about her work at the NIH Clinical Center Read more > >

  

A MESSAGE TO READERS

A Look at Palliative Care

In this issue you will notice several articles related to the important topic of palliative care. For a list of NCI resources on this topic, look for the box at the end of the Guest Director’s Update.

IN DEPTH

UPDATES

  • Notes

    • Free Telephone Workshop Series for Cancer Survivors
    • Print Your Own Copies of Selected NCI Patient Education Booklets

Selected articles from past issues of the NCI Cancer Bulletin are available in Spanish.

The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI), which was established in 1937. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.

For more information about cancer, call 1-800-4-CANCER or visit http://www.cancer.gov.

NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.

Featured Article

I-SPY2: Breast Cancer Trial Aims to Speed Drugs to the Clinic

I-SPY2 trial logoOn March 17, the Foundation for the National Institutes of Health and its Biomarkers Consortium announced the launch of the I-SPY2 breast cancer clinical trial, a novel, adaptive clinical study designed to move promising new drugs into phase III clinical trials more quickly and cost effectively than traditional phase II studies.

I-SPY2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2) will use biomarkers to identify women who might benefit from investigational new drugs given along with standard neoadjuvant chemotherapy (chemotherapy given before surgery) with paclitaxel, doxorubicin, and cyclophosphamide. The trial will enroll women who have early-stage breast cancer and a high risk of recurrence, as determined by estrogen receptor status, HER2 status, and the MammaPrint test.

“It takes 15 to 20 years to develop a new drug for cancer, at an enormous cost—$700 million to $1 billion—depending on the drug and the complexity of the disease being targeted. This cannot continue,” commented NCI Deputy Director Dr. Anna Barker. “It’s unsustainable, and it contributes significantly to rising health-care costs.”

The neoadjuvant setting of the trial is particularly important, explained Dr. Laura Esserman, professor and director of the Carol Franc Buck Breast Care Center at the University of California, San Francisco, and a co-principal investigator of the trial. “In trials enrolling patients with metastatic disease, it can take 2 to 5 years to find out if a new drug extends survival. In the adjuvant setting, we have to wait 5, maybe 10 years to learn whether or not our drugs are saving lives. But in the neoadjuvant setting, we learn at the time of surgery—in less than a year—whether or not a drug has been effective” in those patients, she explained.

Investigational Drugs to be Tested

I-SPY2 will test up to 12 investigational new drugs, each from a different class of therapeutic agent. Information on the results from all drugs will be shared among participating pharmaceutical companies to help guide future work on drugs in the development pipeline. The first five drugs for I-SPY2 have already been selected by an outside advisory committee:

  • ABT-888 (veliparib), a PARP inhibitor developed by Abbot Laboratories
  • AMG 655 (conatumumab), an APO-TRAIL inhibitor developed by Amgen
  • AMG 386, an angiogenesis inhibitor developed by Amgen
  • CP-751,871 (figitumumab), an IGFR inhibitor developed by Pfizer, Inc.
  • HKI-272 (neratinib), a pan-ERbB inhibitor developed by Pfizer, Inc.

This rapid knowledge gain will allow I-SPY2 investigators to test as many as 12 new investigational drugs (see sidebar) from many different pharmaceutical companies that have agreed to cooperate and share data from the trial. If a drug fails to show efficacy in any subgroup of patients, that drug will be dropped from the trial and replaced with another investigational drug in the I-SPY2 queue.

“Most companies have many drugs in their pipeline. What they need to do is fail or succeed early” to minimize the cost and time devoted to testing, said Dr. Esserman.

The patient subgroups in the I-SPY trial will be classified by biomarkers, which are genetic or biologic properties of a tumor that can be measured accurately and reproducibly. The biomarkers to be used in I-SPY2 fall into three categories: standard biomarkers, such as the estrogen receptor and HER2, which are known to correlate with breast cancer prognosis; qualifying biomarkers, which are thought to be related to the drugs being tested but have not yet been validated in clinical trials; and exploratory biomarkers, which will be taken from genome-wide sequencing studies performed during the trial.

Any drug that demonstrates an 85 percent chance of being successful in a phase III trial in one or more biomarker-defined subgroups of patients, as determined by statistical methods developed for the I-SPY2 trial, will be “graduated” from I-SPY2 and replaced with another drug awaiting testing, explained Dr. Donald Berry, a co-principal investigator of I-SPY2. The promising drug will be sent for phase III testing in women whose tumors have the biomarker signature that helps predict the drug’s success.

“Oncology drug development has been hampered in the past by inefficient design in the early clinical trial stages,” commented Dr. Berry, who is also professor and chair of the Department of Biostatistics at the University of Texas M. D. Anderson Cancer Center. Instead of testing a new drug in all patients with a particular type of cancer, he explained, I-SPY2 will use Bayesian updating (a statistical method) to adaptively focus on subgroups of breast cancer patients who might need to be treated differently from others.

All participants in I-SPY2 will have blood and tumor tissue samples tested for the three categories of biomarkers and will undergo MRI scans before and during treatment. Biomarker analysis will be aided by a broad, collaborative information infrastructure that was set up during the proof-of-concept I-SPY1 trial and includes tools developed by caBIG. One such tool, caIntegrator, allows molecular information, imaging data, and clinical observations to be combined for prediction of a drug’s effect on disease progression and survival.

As the trial progresses, patterns of biomarkers from women whose tumors have responded to a particular drug will be used to select additional participants who are more likely than other women to benefit from that drug. The investigators also hope that the biomarker signatures will allow for the development of smaller, more focused phase III trials.

“The phase III trial size that we’re aiming for is 300 patients—that’s an order of magnitude less than the thousands we need for a traditional phase III trial,” explained Dr. Berry. “We can do that because we’ll be looking at a subset of patients in which we already think a drug will be effective.”

—Sharon Reynolds

Funding Sources

The I-SPY2 trial will cost approximately $26 million over 5 years. The trial funding has been coordinated through the Foundation for the National Institutes of Health and includes diverse private sources such as the Safeway Foundation, Johnson & Johnson, Genentech, and Lilly. Additional funding is being sought from corporate partners, nonprofit cancer organizations, philanthropic foundations, and individuals.

Cancer Research Highlights

Many Older Colorectal Cancer Patients Do Not Receive Adjuvant Chemotherapy

Only half of patients age 75 or older with stage III colorectal cancer receive post-surgical chemotherapy, despite data from clinical trials showing that such treatment improves survival across age groups, researchers reported last week. Limited clinical trial data on older patients and toxicity concerns are often cited as the reasons those over age 75 aren’t always given potentially beneficial treatments, but in this study older patients who received chemotherapy were no more likely to have an adverse event than younger patients. The study, which was published in the March 17 Journal of the American Medical Association (JAMA), is part of the NCI-funded Cancer Care Outcomes Research and Surveillance (CanCORS) program.

The findings should prompt clinicians to more carefully consider adjuvant chemotherapy for older patients, as well as encourage the development of clinical trials involving older patients, said study co-author Dr. Robert H. Fletcher of Harvard Medical School during a JAMA-sponsored press briefing.

To conduct the study, Dr. Katherine L. Kahn of the RAND Corporation and colleagues analyzed data on 675 patients diagnosed with stage III colon cancer who had been treated at institutions across the country from 2003 through 2005. Overall, 75 percent of patients received any form of adjuvant chemotherapy, but only 50 percent of the 202 patients age 75 and older received the treatment, compared with 87 percent of younger patients. Older patients who did receive adjuvant therapy tended to be healthier, but they were also more likely to receive lower doses of chemotherapy and to discontinue treatment early. When the researchers adjusted for factors that differed between the younger and older patients, however, including the dose and type of chemotherapy received, older patients actually had fewer adverse events than younger patients, Dr. Fletcher said.

While the limited use of chemotherapy in older patients could be attributed in part to “wise clinical judgment,” Dr. Fletcher said, the study results “raise the likelihood that there is some element of undertreatment here.”

Drug Slows Progression of Cutaneous T-Cell Lymphoma

In a randomized trial of denileukin diftitox (ONTAK) for the treatment of cutaneous T-cell lymphoma (CTCL), a type of non-Hodgkin lymphoma that begins in the skin, patients who received the drug survived without progression of their disease for a median of more than 2 years, compared with just over 4 months for patients who received a placebo. Results from the trial, sponsored by Eisai, the pharmaceutical company that manufactures the drug, were reported March 8 in the Journal of Clinical Oncology.

Denileukin diftitox (DD) consists of a toxin derived from the diphtheria bacterium attached to human interleukin 2 (IL-2), a protein produced by the immune system. The IL-2 binds preferentially to CTCL cells, delivering the toxin to the tumors.

An international group of researchers led by Dr. H. Miles Prince of the University of Melbourne, Australia, enrolled 144 patients who had received three or fewer prior treatments for CTCL into the trial. Participants received one of two different doses of DD (either 9 micrograms or 18 micrograms per kilogram of body weight per day) or a placebo.

Each course of treatment consisted of once-daily infusions for 5 days followed by 16 days of rest, for up to eight courses (approximately 6 months). Treatment stopped if a patient’s disease progressed or if they experienced unacceptable side effects.

Overall response rates (either complete or partial tumor regression) were 49.1 percent in the group receiving the higher dose of DD, 37.8 percent in the group receiving the lower dose, and 15.9 percent in the placebo group. Patients receiving the higher dose of DD had a 73 percent reduction in the risk of disease progression or death compared with patients receiving the placebo. More patients receiving DD reported side effects, though the incidence of serious toxic effects was relatively low in all treatment arms.

Prognostic Marker for Hodgkin Lymphoma Could Improve Care

Researchers have identified a biological marker that could identify patients with Hodgkin lymphoma who are likely to relapse and could benefit from aggressive therapy early in their treatment. The biomarker is the number of white blood cells called CD68-positive macrophages present in a biopsy from a patient’s lymph nodes. Testing for this marker could easily be incorporated into clinical practice, the researchers reported in the March 11 New England Journal of Medicine.
 
Dr. Christian Steidl of the British Columbia Cancer Agency and his colleagues analyzed tumor samples from nearly 300 patients. They found that increased numbers of tumor-associated macrophages were strongly associated with shortened survival.

“These results will now allow us to design clinical trials that enroll only the high-risk patients with Hodgkin lymphoma, thereby accelerating the testing and validation of new therapies aimed at abnormal regulatory pathways in these tumors,” said co-author Dr. Louis Staudt of NCI’s Center for Cancer Research.

About 75 to 80 percent of patients with Hodgkin lymphoma are cured by their initial treatments, but the others relapse. Advances in treatment have stagnated for 20 years because researchers have lacked markers for predicting the response to therapy, according to an accompanying editorial. This lack of markers has also contributed to the overtreatment of many patients with Hodgkin disease, wrote the authors of the editorial, Drs. Vincent DeVita and Jose Costa of the Yale Cancer Center.

The new findings “appear to be the breakthrough we have been looking for by enabling the selection of patients with particularly poor prognosis (regardless of stage) for aggressive treatment, which can bring more logic to the treatment of this curable cancer,” the editorialists concluded.

Nanoparticle-based Therapy Triggers RNA Interference in Human Tumors

An experimental therapy designed to block the production of a protein in tumor cells through a mechanism known as RNA interference, or RNAi, has shown promise in an early-stage clinical trial. Cells use RNAi to regulate the activity of genes, and this mechanism could potentially be harnessed for turning off genes in the cancer cells of patients, according to findings reported online in Nature on March 21.

In a proof-of-concept study involving three patients with melanoma, the researchers injected targeted nanoparticles into the blood to carry small interfering RNA (siRNA) molecules into tumors. These nanoparticles were designed to bind to the transferrin receptor, which is expressed at high levels by cancer cells, and they included an siRNA directed against a subunit of ribonucleotide reductase 2 (RRM2). This protein is involved in DNA replication and is an important target for anticancer therapies.

Analyses of the patients’ tumors revealed that, once inside the cell, the siRNAs inhibited the production of the RRM2 protein by triggering the destruction of the protein’s messenger RNA. The researchers also detected a dose-dependent accumulation of nanoparticles; that is, higher doses of nanoparticles administered led to a higher number of nanoparticles in tumors. The researchers note that this is the first time that dose-dependent accumulation of targeted nanoparticles has been observed in human tumors. The researchers plan to present clinical results from the trial at the American Society of Clinical Oncology annual meeting in June.

“We were able to confirm both pieces of the puzzle—that the delivery vehicle got where it was supposed to go and that the observed effects occurred though the mechanism of RNAi,” said lead investigator Dr. Mark Davis of the California Institute of Technology, whose team has been working on the project for more than a decade. A primary challenge has been finding ways to deliver siRNAs, which degrade rapidly in the body.

“This study describes an effective way of delivering a fragile construct and represents a very important application for the use of nanotechnology in therapeutic delivery,” said Dr. Piotr Grodzinski, program director for the NCI Alliance for Nanotechnology in Cancer. “Nanoparticles may be one of the only effective ways to deliver siRNAs.”

Patients with other types of cancers are participating in the clinical trial, which was sponsored by a company started by Dr. Davis, Calando Pharmaceuticals. The analysis of tumors was supported in part by NCI.

Guest Director's Update

Improving Delivery of Quality Cancer Care

Dr. Ann O’Mara and Andrea Denicoff Dr. Ann O’Mara and
Andrea Denicoff

During a recent meeting with NCI-funded investigators at Memorial Sloan-Kettering Cancer Center in New York, we saw an older gentleman sitting in the waiting room, his wife by his side, with a small tablet PC on his lap. He was, we learned, completing a questionnaire about any symptoms or side effects he was having from the treatment he was undergoing for metastatic prostate cancer.

“Why are they asking me all of these questions?” he wondered aloud.

Because, we replied, otherwise he might not volunteer the information to the treating oncology staff.

His wife chimed in. “That’s right. He would never tell them these things. He wouldn’t want to bother them with it.”

The conversation affirmed an important fact: Patients often don’t report, or tend to underreport, the problems they are experiencing as a result of their cancer treatment or because of their underlying cancer. Unless, of course, they are asked. Only if a problem is identified can a solution be delivered, or at the very least sought out.

Although palliative care is often equated with end-of-life care, they are not the same. Palliative care is about helping patients maneuver through the travails of cancer diagnosis and treatment, regardless of whether they have early-stage cancer that is highly curable or more advanced disease for which the treatment goals are extending survival as long as possible with as good a quality of life as possible. And according to a recent review we conducted, efforts to achieve survival with good quality of life are progressing, with clinical trials that better capture patients’ experiences during their treatment. That information, in turn, is improving our ability to help patients manage quality-of-life issues, often through palliative care services.

To conduct the review, we looked at NCI-sponsored phase III clinical trials of the four major cancers (breast, prostate, colorectal, and lung) that were published or launched over the last 2 decades to assess their use of health-related quality of life (HRQOL) measures. These measures assess changes in patients’ health status—aside from their underlying cancer—as a result of their treatment, such as changes in bowel function, fatigue, or neuropathy (tingling or burning sensations in the hands or feet, numbness in certain areas, among other things). Several clear trends emerged.

For instance, over time, the number of measures that patients are being asked to assess, often called patient-reported outcomes, have increased. And, second, more trials have begun to shift from global HRQOL measurements to more symptom-specific measures, such as sexual function after prostatectomy.

This shift is important, because while patients may report that, overall, treatment has not altered their health that much, when asked about specific symptoms that can have a significant impact on their day-to-day lives, they are more likely to report them. For example, in one trial that tested two different adjuvant chemotherapy regimens in patients with stage II or III colon cancer, the trial investigators learned that there were significant differences in the impact of the two treatments on patients’ reports of weakness and hand/foot pain related to cold. Having reliable information about symptoms can allow oncology professionals to prepare patients for what they may expect from given treatments and, as we gain more information and experience with different treatment regimens, to learn how these symptoms can be effectively managed or perhaps prevented altogether.

Unfortunately, progress has lagged in developing evidence-based treatments for symptoms and toxicities related to different cancer therapies. In many cases, such as the skin toxicities associated with the use of EGFR inhibitors, we still need to better understand why, at a biologic or physiologic level, patients experience these toxicities so that treatment options that will not interfere with cancer therapy can be developed and tested.

Some studies directly testing palliative treatments, including groundbreaking work by Dr. Betty Ferrell and colleagues at City of Hope cancer center, are already moving ahead. And we eventually hope to begin incorporating palliative care studies into randomized trials of new cancer therapies, something that has been a matter of much discussion and that we will continue to explore at NCI and with clinical trial investigators.

We are also seeing a growing interest in and support for palliative care training programs. So, as we develop more evidence-based treatments for the broad-ranging effects of cancer therapies, we will have a more highly trained workforce that can work in collaboration with treating oncologists to ensure that they are effectively delivered.

Overall, we are clearly witnessing a transition in clinical cancer research, where a higher priority is being placed on gaining the information and taking the steps needed to more effectively treat the whole patient. And that is very encouraging. Because, of course, we want to save lives—as many as possible. But if we truly believe in the idea of personalized medicine, then we must embrace the notion that cancer treatment and a poor quality of life do not go hand-in-hand.

Dr. Ann O’Mara
Head of Palliative Care Research, Community Oncology and Preventive Trials Research Group
NCI Division of Cancer Prevention

Andrea M. Denicoff
Nurse Consultant, Clinical Investigations Branch, Cancer Therapy Evaluation Program
NCI Division of Cancer Treatment and Diagnosis

NCI Resources on Palliative Care

Fact sheet on palliative care
http://www.cancer.gov/cancertopics/factsheet/support/palliative-care

Patient information on coping with cancer
http://www.cancer.gov/cancertopics/coping

Supportive and palliative care clinical trials
http://www.cancer.gov/cancertopics/coping/supportive-clinical-trials

NCI’s Symptom Management Twitter feed
@NCIsymptomMgmt

Guest Commentary by Dr. Andrea Barsevick

Fatigue: Is it Normal or Pathological? And How Can We Best Treat It?

Dr. Andrea Barsevick Dr. Andrea Barsevick

Despite years of scientific study of cancer-related fatigue (CRF), questions related to its definition, measurement, underlying mechanisms, and effective interventions remain unanswered. Yet, the high prevalence of CRF and its negative effects on quality-of-life outcomes, including work and family functioning, make it a critical problem for cancer patients and survivors. Clearly, more research is needed to reduce morbidity associated with this symptom.

To address this, on April 13 and 14, NCI’s Symptom Management and Health-related Quality of Life Steering Committee will convene a closed-attendance state-of-the-science meeting on CRF, which I will chair. During this meeting, we will summarize the science, address gaps in knowledge that require further study, and develop a focused agenda for future research.

The steering committee is a group of scientists, clinicians, and patient advocates who have been working together since 2007 to evaluate the scientific quality of proposed trials testing symptom and quality-of-life interventions. This group also convenes periodic state-of-the-science meetings to address critical questions that could improve the evaluation and prioritization of NCI-supported clinical trials.

Why is CRF such a difficult symptom to understand? Why have we been unable to develop effective therapies to prevent or treat it? Part of the answer may lie in the fact that, unlike many other symptoms, fatigue can be caused by both disease and treatment. Also, in everyday life, people without cancer experience fatigue. As a result, the line between fatigue as a normal occurrence and fatigue as a pathological symptom is blurred.

There has been progress, however, in our understanding of this subjective phenomenon. Diagnostic criteria for CRF have been proposed for further evaluation, and new measurement methods have been developed. Recently, researchers have started to examine the underlying biology of this symptom from a mechanistic perspective, which will be necessary for those who go on to develop new therapies to treat it.

Nurses have provided important leadership in these areas of research. Dr. Christine Miaskowski and her team at the University of California, San Francisco, for example, have contributed to our understanding of the biology of CRF. Dr. Barbara Piper at the University of Arizona has been a pioneer in fatigue measurement. And Dr. Debra Barton of the Mayo Clinic determined that a nutritional supplement (American ginseng) was effective in reducing CRF. In my own lab at Fox Chase, we have found that a behavioral intervention (energy conservation and activity management) also reduces CRF. These researchers and several others will be contributing to our state-of-the-science discussion to determine how we can build on our current knowledge base and deliver the greatest benefit for cancer patients.

With the progress that has been made and the significant challenges that remain, the NCI steering committee members and I decided to focus our efforts by bringing together experts in the behavioral and biological aspects of CRF and in research design and methods to develop new hypotheses and methods for the study of CRF. The recommendations that result from our meeting will be published, presented at scientific meetings, and distributed to government agencies and foundations that fund symptom research. Critical issues that arise during the proceedings may become the subject of additional publications.

Perhaps the best way to appreciate the urgent need to better understand and treat CRF is from the perspective of cancer patients and survivors who have experienced it. In discussing CRF, invariably they talk about their inability to get out of the house, work, cook meals and do dishes, get up the stairs to go to bed, or do half the things they did before. It is for these reasons that scientists need to fill the gaps in our knowledge of CRF.

Dr. Andrea Barsevick
Associate Professor and Director of Nursing Research
Fox Chase Cancer Center

A Conversation With

A Conversation with Dr. Ann Berger on Palliative Care at NIH

Dr. Ann Berger Dr. Ann Berger

Dr. Ann Berger is chief of the NIH Clinical Center’s Pain and Palliative Care Service (PPCS), which she founded in 2000. The PPCS functions as a consult service for clinical teams and patients who are enrolled in clinical trials at the NIH hospital in Bethesda. More than half of the patients seen by Dr. Berger and her team have cancer and are enrolled in NCI-sponsored clinical trials. Dr. Berger has written extensively about pain management and palliative care, including a book for the lay audience, Healing Pain: The Innovative, Breakthrough Plan to Overcome Your Physical Pain and Emotional Suffering, published by Rodale Books in 2006.

How does the PPCS function within the NIH Clinical Center?

Our core team consists of two nurse practitioners, three full-time attending physicians, an administrative coordinator, and me. We assess patients and decide who will benefit them the most from the larger interdisciplinary team, which includes members of the spiritual ministry, social workers, recreational therapists, dieticians, pharmacists, rehabilitative medicine practitioners, psychiatrists, and also those who work in complementary modalities, such as acupuncture, pet and art therapy, massage therapy, hypnosis, and energy work in the form of Reiki. We see this interdisciplinary collection of skills as part of our overall tool box, along with medications.

We usually work with patients over a long period of time, because we believe that they should be followed across the trajectory of their disease. So, for example, if a person is enrolled in a bone marrow transplant clinical trial, we see them on day one, along with their transplant team, during a meet-and-greet session. We do a palliative care assessment to get a sense of their baseline physical, psychosocial, and spiritual status—who they are and how they tick, essentially—so that when they start to go through the process, we can help them more effectively. We’re with them for their transplants; the radiation; the nausea and vomiting and mucositis; the graft-versus-host disease (GvHD). We come with balloons and parties and we sing and dance, when appropriate, and we’re also there for end-of-life care, if that happens. We also get to know the family members of patients and their psychosocial and spiritual issues, which can make end-of-life care a lot easier for everyone concerned, including the staff.

For patients who have died, we hold a memorial service every year and invite staff to attend. And we conduct bereavement follow-up care for the family members at 2 months, 6 months, 9 months, and 1 year.

This sounds like a lot of work for such a small team. How do you manage to do it?

We have a team of volunteers who help us, and we just move. I’ve seen health care from many different angles. I have a master’s degree in oncology nursing, I’m a physician, and I’m also a breast cancer survivor. I had bilateral mastectomies and I’ve also had heart surgery, both times while my children were still young. I can put myself in these patients’ shoes because I have been in their shoes. So it’s easy, and we just do it.

Do you have your own research protocols?

We function mostly as a clinical service, but we also do research because we’re part of a research institution. We ran a pet therapy protocol, for example, and also a hypnosis protocol with sickle cell patients. We had a larger study with the nursing group at the hospital looking at the efficacy of palliative care, where patients were randomized to receive our service or not. We’ve also run protocols with GvHD patients, because we see every one of them at the hospital. So, we usually write up things that are practical in the course of our normal care with patients.

Our biggest current area of study is part of a training program looking at the meaning of healing. We talk about healing a lot in palliative care. We say that patients may not be cured of their illness, but they can be healed; that the healing brings them a sense of “wholeness.” But what exactly is this phenomenon? We’ve now interviewed 10 patients who survived cancer and described being healed, in 3-hour in-depth sessions, and we’re analyzing their testimonies. We’re going to speak with patients who have survived cardiac conditions, also, to see what the experience of healing meant for them. We want to understand what this is and how people can get there, and then see if there’s a way to quantify the experience so that health care providers can help other patients achieve the same thing.

What is holding back palliative care around the country, and what can be done about it?

One simple thing that patients can do is to ask for palliative care, and ask for it early. They can give a list of their symptoms to their health care providers—pain, depression, stress about finances, concerns about their children, for example—and ask, Is there a palliative care team here that can help me? Are there people who can help me with my quality of life? These services are becoming more and more available, and if there isn’t an established palliative care service at the institution where a patient is being treated, the American Academy of Hospice and Palliative Medicine maintains a list of practitioners that people can refer to.

The biggest institutional obstacle to palliative care is the struggle between cure and palliation. On the oncology side, many still see palliative care as end-of-life care and not in broader terms. And even in the palliative care community, many still convey themselves as end-of-life caregivers. So, it’s a problem that’s being perpetuated on both sides.

If someone wants to start a palliative care service at a hospital or clinic, they need to begin at the bedside helping one patient at a time, to show everyone what they can do, because many people still don’t know what palliative care is. They need to treat the service that they want to establish as if it were a private practice: be there, be available, and, also, be palliative for other staff members.

Clinical staff members need palliative care, too?

The primary unit of palliative care is the patient and family. But much of what we do is also palliative care for staff. It’s very difficult to take care of critically ill patients, particularly those who have cancer. I talk about this when I’m asked to give lectures on burnout. Many of the things that we do for patients can also be done for staff members at the hospital.

It can be very difficult for oncologists to lose patients. And so sometimes we run into struggles when we talk with them about the best balance between aggressive treatment and comforting a patient at the end of life. We as palliative care staff need to be sitting down with the oncologist and asking, “Hey, is this difficult for you right now?” Everybody wants to help the patient. Nobody is trying to do them harm. And there usually isn’t only one right way to do something.

So yes, palliating the staff is something that needs to happen, too, because if you don’t, you’ll just end up fighting and you won’t have a successful team. Our team is very successful. We have 700 new patients each year and 7,000 follow ups a year. We’re the busiest service in the hospital.

Brittany Moya del Pino

Special Report

Common Genetic Variants Modestly Improve Breast Cancer Risk Models

More than a dozen common genetic variants have been linked to breast cancer in recent years, largely through genome wide association studies. While each variant—a single nucleotide polymorphism or SNP—contributes modestly to a woman’s overall inherited risk of the disease, some researchers have suggested (in the Journal of the National Cancer Institute and New England Journal of Medicine) that current breast cancer risk models could be improved by profiling women for panels of these variants.

This idea has now been tested for the first time in a large population of women. The researchers found that a model based on the profile of 10 common SNPs (“snips”) associated with breast cancer risk did a better job of predicting which women would develop the disease than a standard risk-prediction model based on a questionnaire that asks about traditional risk factors, though the improvement was minor.

“We found that adding SNPs to the questionnaire model made a noticeable difference in the model’s performance—that is, it improved the ability to stratify women according to different levels of risk,” said lead investigator Dr. Sholom Wacholder of NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “We also found, however, that the stratification provided by the model was still not adequate to inform clinical practice.”

Current genomic markers of risk for breast cancer do not offer significant information beyond traditional methods of estimating risk. - Dr. Kenneth Offit

The addition of the SNPs to the standard model led to a tool that was slightly better than the other two models (SNPs alone or the standard model alone). But even with this improvement, it is not yet possible to identify women at reduced or increased risks of the disease in a clinically useful way, the researchers concluded in the March 18 New England Journal of Medicine.

New Genetic Information

“One way to look at the results,” said Dr. David Hunter, the study’s senior author and director of the Program in Molecular and Genetic Epidemiology at the Harvard School of Public Health, “is that the new genetic information, acquired in just the last 3 years, gives as much predictive value as the classic risk factors that were the fruits of the previous many decades of breast cancer epidemiological research.”

The study compared the SNP-based model with NCI’s Breast Cancer Risk Assessment Tool, which takes into account a woman’s medical and reproductive history as well as her family history of the disease. Commonly known as the Gail model, this tool is used by health care providers to discuss breast cancer risk with their female patients.

The addition of the genetic variants did shift a small proportion of women from one risk group to another. But only 34 percent of the women who actually had breast cancer in the study were assigned to the top 20 percent risk group by the combination model, the researchers found. In a highly effective risk-prediction model, 80 percent of the women with breast cancer would have been assigned to this group, according to the researchers.

“The message of this study is that current genomic markers of risk for breast cancer do not offer significant information beyond traditional methods of estimating risk,” said Dr. Kenneth Offit, chief of Clinical Genetics Service at Memorial Sloan-Kettering Cancer Center, who was not involved in the research. “The study also reminds us that traditional methods of breast cancer risk assessment need to be further refined.”

Effective models for assessing breast cancer risk would allow doctors to determine where an individual woman falls along a continuum of risk levels. Women at the highest levels of risk could consider aggressive prevention measures, such as more frequent mammograms and taking the drug tamoxifen.

For women seeking advice on their individual risk of breast cancer, it is too early to incorporate SNP testing into a counseling procedure, although such tests for this purpose are already advertised on the Internet, noted the authors of an accompanying editorial, Drs. Peter Devilee of Leiden University Medical Center and Matti Rookus of the Netherlands Cancer Institute.

To compare risk estimates, the study authors assembled genetic and clinical information on 5,590 women with breast cancer and nearly 6,000 without the disease. The women in the study were predominantly white, between the ages of 50 and 79, and had enrolled in four prospective studies in the United States and one case-control study in Poland.

“We have concluded that more knowledge about what causes breast cancer is needed—both from genetic and environmental epidemiology,” said co-author Dr. Patricia Hartge of DCEG. “Until we have that information, the predictive accuracy of these models is going to be limited.”

Tip of the Iceberg

Clearly, additional SNPs and other types of inherited genetic variants that influence breast cancer risk, including structural changes to chromosomes and gene mutations, remain to be found. The 10 SNPs in the study account for less than 5 percent of the familial risk for breast cancer in the population, Drs. Devilee and Rookus said. By comparison, mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 are rare but account for nearly 25 percent of the familial risk for the disease.

“This study provides an important and sobering look at the complex nature of the inherited genetic contributions to breast cancer,” said coauthor Dr. Stephen Chanock, who directs the Laboratory of Translational Genomics in DCEG. “With this preliminary look, we are starting to see the usefulness of SNPs, but there are additional common, uncommon, and rare genetic variants still to be discovered.”

In terms of genetic variants associated with breast cancer, the 10 SNPs represent “no more than the tip of the iceberg,” the editorial authors noted. As a more complete picture emerges over time, researchers can use the new information to improve the models, Dr. Chanock said.

Meanwhile, researchers are trying to uncover the precise sources of the genetic risk captured by each SNP. The SNPs are essentially markers of chromosome regions that harbor genetic variation associated with breast cancer risk. Information about the functional effects of the SNPs could ultimately lead to more accurate risk predictions, the researchers said.

The best way to think about the study, said Dr. Offit, is as part of a process of developing evidence for starting to translate genomic discoveries into the practice of preventive medicine. Once a more complete catalog of genetic variations involved in breast cancer risk has been developed, it will be critical to consider the effects of these markers together and not individually, he continued.

“When this range of studies is completed,” Dr. Offit added, “it may then be possible to provide genomic profiles to personalize the prevention of breast cancer.”

Edward R. Winstead

Spotlight

Communications
This is the third article in a series of stories related to cancer communications. Look for the symbol on the left in an upcoming issue for the next article in the series.

Training Providers and Patients to Talk about End-of-Life Care

It has been observed and documented widely; most doctors and patients do not want to talk about death and dying. But failing to discuss transitions of care—from active cancer treatment to end-of-life care once treatment options have been exhausted—can leave doctors unsure of what a patient truly wants at the end of his or her life. And failing to receive end-of-life care in line with their values and wishes can cause both patients and their families great distress.

We think that by focusing on the emotional content of conversations, all decision making will go better. - Dr. James TulskyAn article recently published in Cancer based on findings from the NCI-funded Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) reported that most doctors would not initiate discussions about end-of-life care options with terminally ill patients who still felt well. Instead they waited for symptoms or until there were no more cancer treatments to offer. Physician discomfort with these discussions contributed to the unlikelihood of their occurrence; doctors who did not feel confident in the realm of end-of-life discussions were less likely to initiate them, until the last minute.

“These are difficult conversations,” said Dr. Ann O’Mara, head of Palliative Care Research in NCI’s Community Oncology and Prevention Trials Research Group. “And most physicians aren’t trained to have these conversations and don’t feel comfortable having them.

“While we have to draw an emotional line with patients—you can’t get so involved that you lose sight of being a clinician—we still need to have empathy,” she continued. “We have too many patients saying that their doctors don’t understand what they’re going through, or don’t want to understand.”

Re-learning How to Talk

Researchers have developed a number of innovative, evidence-based programs to help both doctors and patients improve their communication skills and grow comfortable with discussions about moving from cancer treatment to end-of-life care.

Dr. Anthony Back, professor of medicine at the University of Washington, Seattle, developed the Oncotalk program to fill in an important element that he and his colleagues saw was missing in medical oncology fellows’ training: how to speak with empathy.

“Learning to communicate really requires a different kind of teaching, a different kind of teacher, and a different kind of learning experience than most of what is learned in medical school, which is a didactic, you-listen-to-the-experts kind of thing,” explained Dr. Back. “That’s not how you become a better communicator.”

Dr. Back and his colleagues teach Oncotalk in an intensive retreat format over the course of 4 days each year, covering issues in cancer communication from diagnosis to end of life: fundamental communication skills, giving bad news, managing transitions to palliative care when chemotherapy is failing, talking about advance care plans and do-not-resuscitate orders, discussing treatment options and informed consent, conducting a family conference, handling requests for therapies that a doctor feels are futile, and cultivating communication skills.

“We developed Oncotalk using a theory of communication tasks that goes all along the cancer trajectory, so clinicians will start to think of these different tasks in different ways, and so that they approach patients in a way that’s more specific to where they are in their cancer journey,” said Dr. Back. “We frame the job of the doctor as a guide or a coach; it’s not just about giving bad news.”

In a peer-reviewed validation of the program, which enrolls about 40 fellows per year, participants demonstrated more than 10 new communication skills in simulated patient encounters after the workshop than they displayed before participation.

“I feel less flustered and my words are less tangled; I can focus on the person across from me and find out what they need from me in that moment,” wrote Dr. Lanie K. Francis in an article published in the Journal of Clinical Oncology after completing an Oncotalk retreat.

In collaboration with Dr. J. Randall Curtis, also from the University of Washington, Dr. Back is now performing a randomized study of an Oncotalk-based curriculum for internal medicine residents and advance-practice nurses, broken up into half-day training sessions, to see whether the skills can be effectively taught outside the intensive-retreat format, and to quantitatively measure their impact on patients’ satisfaction with their end-of-life care.

Communicating Empathy

Dr. James Tulsky, director of the Center for Palliative Care at Duke University and an Oncotalk faculty member, has developed a Web-based video training course to increase oncologists’ use of empathic language when they are talking with their patients. “Patients want physicians to listen to them, to understand them; they want them to be in tune with their concerns,” he said.

He and his colleagues performed a preliminary study of 400 doctor-patient conversations and found an important emotional component of this communication to be largely missing. “When patients raised what we call empathic opportunities—these moments where they state something that has emotional weight to it, something that demands an emotional response—physicians responded using empathic language only about a quarter of the time,” he recounted.

Dr. Tulsky then tested their Studying Communication in Oncologist Patient Encounters (SCOPE) intervention in a clinical trial in which 48 oncologists were randomly assigned to either personalized computer-based training—in addressing patients’ emotional concerns and communicating bad news and prognoses—or a control group who received no further training. After an average exposure to the training material of just over an hour, oncologists who received the training were more than twice as likely compared with the control group to use empathic language when talking to their patients, measured in recorded conversations after the intervention.

The researchers led by Dr. Tulsky are now performing a clinical trial taking the same principles and using them with patients, “to help them better get their emotional needs met when they see their oncologists,” he said.

The Patients’ Perspective

“We can get doctors to better respond to emotional cues, but at the same time, it seems like patients have been socialized not to even bring these issues up, or they just don’t know how to,” explained Dr. Tulsky. “But there’s a lot of data that shows that the more that people can express what’s on their minds, the more likely they are to feel better and decrease their stress.”

The patient-centered intervention, called Communication in Oncologist Patient Encounters (COPE), uses a Web-based intervention that is similar to SCOPE. With COPE, patients can review audio recordings of their encounters with their oncologists as well as videotaped examples of communication skills they can use with their doctors.

In the COPE trial, after reviewing the videos, patients will then have their next visit with their oncologist recorded and discussed with the investigators. “We’ll try to highlight where they used the skills we’re teaching, and where they could have tried to use them but didn’t,” explained Dr. Tulsky.

The ongoing COPE trial is enrolling 400 patients with advanced cancer into four study arms: a control group with internet access alone; the COPE intervention; an interactive, internet-based communication system called CHESS; or COPE plus CHESS. Developed by the University of Wisconsin’s Center of Excellence in Cancer Communications Research, CHESS (Comprehensive Health Enhancement Support System) was designed to help individuals cope with a health crisis or medical concern, and includes information, social support, and decision-making and problem-solving tools.

The researchers will measure changes in participants’ willingness to express emotional concerns and request emotional support during their doctor-patient visits, as well as how they feel after their appointments. “We think that by focusing on the emotional content of conversations, all decision-making will go better,” said Dr. Tulsky.

Sharon Reynolds

A Closer Look

Treating the Whole Person in the City of Hope Lung Cancer Study

Dr. Betty Ferrrell and Tami Borneman are colleagues at City of Hope’s Beckman Research Center, where they devote themselves to palliative care and quality-of-life issues. Dr. Betty Ferrrell and Tami Borneman are colleagues at City of Hope’s Beckman Research Center, where they devote themselves to palliative care and quality-of-life issues.

When Dr. Betty Ferrell got her Ph.D. in 1984, she already had 7 years of work as an oncology nurse behind her, and she had absorbed some clinic-tested insights. “Fatigue wastes time, and time is precious,” a patient once told her, and she came to realize that “fatigue is really the existential crisis of cancer.” Symptoms like fatigue, pain, and other inevitable side effects of cancer treatment were dominating the lives of her patients, but she often found that clinicians and researchers were reluctant to address or even acknowledge this fact.

“And when I wanted to study these symptoms as a researcher, I ran into every imaginable brick wall,” she recalled, referring to resistance from sponsors, funders, the institutional review boards that oversee clinical studies, and the cancer research community in general. It was the culture of oncology in America, she said—focused on treating the tumor while pretty much ignoring the human being who was suffering from the disease.

Twenty-six years and more than 300 publications later, Dr. Ferrell believes, “we’ve actually pushed the rock a ways up this huge mountain.” In 2003, the Institute of Medicine released Improving Palliative Care for Cancer, which included a recommendation to “provide information about palliative care throughout the course of disease.” What was needed to dislodge that rock of institutional culture was nothing less than a paradigm shift in oncology.

ALSO IN THE JOURNALS

In 2006, the NCI Cancer Bulletin featured a story about Dr. Ferrell’s implementation of a hospital-wide system called Passport to Comfort, which incorporated patient education into a teaching program that addressed barriers to adequate symptom management at City of Hope. Four years later, Dr. Ferrell and her colleagues have found that their program significantly improved pain and fatigue among patients. The study results appeared in the March Journal of Pain and Symptom Management.

“[This] is one of the first reported trials to translate the National Comprehensive Cancer Network pain and fatigue guidelines into a proven educational intervention,” said lead author Tami Borneman, a nurse and senior research specialist at City of Hope. “Because the intervention integrates information into usual care, we are eager to see the model translated into actual clinical settings.”

Part of that shift is a new NCI-funded program project on palliative care that Dr. Ferrell is leading at City of Hope Comprehensive Cancer Research Center in Duarte, CA, outside of Los Angeles. The new program addresses the physical, psychological, social, and spiritual needs of patients with non-small cell lung cancer and their families.

Lung Cancer as a Context for the Future of Palliative Care

Currently, some 219,000 people in the United States are diagnosed with lung cancer each year, and more than 150,000 die annually. In Dr. Ferrell’s view, “Lung cancer is an important context [in which to study palliative care] because great societal costs come from a disease with such high prevalence, morbidity, and mortality.”

“It is simply not acceptable that the hundreds of thousands who will die should do so without their real needs being met. It is not a question of allocating resources to either cancer treatment or the psychosocial needs of patients. I want both, and I expect the public and the people I love to get both,” said Dr. Ferrell, whose mother died of lung cancer.

Integrating these aspects of oncology is what she and others in the palliative care community have been advocating. In a sense, Dr. Ferrell sees the City of Hope palliative care lung study as the culmination of 25 years of research.

“For the first time, the traditional disease focus found in oncology is being woven together with a meaningful palliative care intervention with validated outcomes,” she said. “We hope this model will demonstrate the key principles of this synthesis.”

“This study is an ideal setting for this tailored research,” said Dr. Ann O’Mara, who leads the Palliative Care Research Program at NCI. Program projects, she explained, often address a larger context than a single study. “People with non-small cell lung cancer are an understudied population when it comes to palliative care, and these patients probably need many of the components that we believe are part of effective interdisciplinary care,” she said.

The City of Hope study includes parallel trials for different populations of lung cancer patients: 207 patients with early-stage disease in one project, and 326 with late-stage disease in another, with nearly identical aims and components. Dr. O’Mara thinks this approach could provide useful comparisons across the spectrum of disease.

A third project in the overall study is recruiting the informal caregiver(s) for each patient in the first two projects to test a palliative care intervention for family caregivers. Not only will the enrolled caregivers pick up skills and knowledge to better support the patients’ needs, but their own quality of life will be measured. Data on caregiver effectiveness will be evaluated according to disease stage and socio-demographic characteristics and compared with data from family caregivers who did not get the supportive intervention.

“It is families, not just people, who get cancer,” Dr. Ferrell explained. A diagnosis of lung cancer often brings emotional and financial burdens that impact others in the family, which points to another vital and strategic aspect of palliative care.

“We are living in an era of outpatient medicine,” she explained. “When I was starting out, people with symptoms or problems would call the hospital, routinely be invited in, and often stay for weeks as the system provided more care. But in the current economic model family caregivers have become ‘professionals’ who are caring for the patients. This is an urgent social issue in public health,” she said.

Oncology: An Existential Relationship

“We have an important opportunity,” said Dr. Ferrell. “I want to transform lung cancer care in the United States. Hundreds of thousands of people each year are directly affected by lung cancer, and we need to see them as individuals, not statistics.”

But she fully agreed that the world of oncology needs data to support evidence-based practice. “If I want my colleagues to treat cancer patients with the integrated care model that we are testing in our program at City of Hope, I’ve got to show them rigorous evidence,” she said. By 2014, she hopes that is exactly what this 5-year, $11 million project will produce.

“If you can move beyond seeing cancer as a biological event and recognize it as a human experience, it will change you,” said Dr. Ferrell. Only by embracing this approach, she went on, will patients “get the interdisciplinary care, support, and understanding they need and deserve.”

—Addison Greenwood

Featured Clinical Trial

Vaccine Therapy for Patients with Progressive Stage D0 Prostate Cancer

Name of the Trial
Phase I Randomized Pilot Study of Epitope-Enhanced TARP Peptide Vaccine Versus TARP Peptide-Pulsed Dendritic Cells in Patients with Biochemically Progressing Stage D0 Prostate Cancer (NCI-09-C-0139). See the protocol summary.

Dr. Jay A. Berzofsky Dr. Jay A. Berzofsky

Principal Investigator
Dr. Jay A. Berzofsky, NCI Center for Cancer Research

Why This Trial Is Important
Treating early-stage prostate cancer with surgery or radiation therapy provides long-term disease-free survival for the majority of patients, but between 30 and 40 percent of men will experience a recurrence of their disease within 10 years. When prostate cancer recurs, those who are eligible often receive androgen deprivation therapy, which can be very effective initially. Eventually, however, the cancer acquires the ability to grow without the help of male hormones, and then the outlook is poor.

Scientists believe that immunotherapy has great potential as an alternative approach in treating recurrent prostate cancer, if it can be used as soon as increasing PSA blood levels indicate that the cancer has recurred and has likely spread beyond the prostate. In the Jewett staging system for prostate cancer, this is called stage D0 disease.

In this phase I trial, researchers are testing a vaccine to treat stage D0 prostate cancer. The researchers are evaluating the safety of the vaccine and whether the body’s immune system will respond to it by producing immune cells called T lymphocytes that will selectively attack cancer cells.

Specifically, the vaccine is designed to stimulate the immune system to attack cancer cells that express a protein called T-cell receptor gamma alternate reading frame protein, or TARP, which has been found in more than 90 percent of prostate cancer samples. The vaccine is made by combining natural and modified fragments (peptides) of TARP that were shown in previous laboratory and animal studies to stimulate T-lymphocyte immune responses.

Because the best method of administering the TARP peptides is unclear, the researchers are testing two different approaches. Half of the patients will receive the peptides along with an immune adjuvant, which is a substance that enhances immune responses set in motion by other agents (vaccines, bacteria, viruses, etc.). The remaining patients will be injected with dendritic cells that were taken from their bodies and exposed to the TARP peptides in the laboratory. Dendritic cells are immune cells that take up substances and display them on their surface to T lymphocytes, stimulating an immune response. Using dendritic cells in this way has shown promise in animal and some human studies.

“This setting is an opportunity to take advantage of recent advances in immunotherapy,” said Dr. Berzofsky. “We are starting to harness the exquisite specificity of the immune system to selectively target cancer cells without harming a patient’s normal cells.”

For More Information
See the lists of entry criteria and trial contact information or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

An archive of "Featured Clinical Trial" columns is available at http://www.cancer.gov/clinicaltrials/ft-all-featured-trials.

Community Update

Palliative Care Education: Focusing on Care and Not Just Disease

At the Institute for Palliative Medicine (IPM) in San Diego, medical residents are re-tooling for one of the most essential aspects of medicine: caring for seriously ill patients.

“The goal is to teach them the core competencies in palliative care,” explained Dr. Charles von Gunten, the institute’s provost.

These competencies include pain management, good communication skills, and the ability to provide patients with psychosocial and spiritual assessments and to work in interdisciplinary teams in hospitals, as well as through hospice and in nursing homes, he said.

Dr. von Gunten started the institute in 1989, when national data showed that patients rated doctors poorly in communications skills and end-of-life care. The need for palliative care has generally been overlooked in the problem-oriented approach that dominates the practice of medicine, he explained, one in which doctors make a list of patients’ problems and try to solve each of them.

“If you are paid per problem, it tends to foster more and more problems. So we end up doing a lot, rather than focusing on doing the most important thing. Our financing system promotes this,” he said.

“It’s very powerful. But it has a fatal flaw, which is that human beings are not a sum of their parts. And, particularly when some of the problems on the list cannot be cured, that system breaks down.”

Dr. von Gunten says technological advancements shouldn’t overshadow the human touch. “There’s the old joke about the Harvard death. It’s okay if the patient dies, as long as the tests are normal,” he said. “You shouldn’t have to choose one or the other. You can have the latest and greatest technology, but that should be in service to the overall goals of medical care, as determined by the patient.”

And addressing patients’ goals includes “not just the patient’s biology, but also his or her spiritual, emotional, and psychological state,” said Dr. von Gunten.

A New Cornerstone of Medical Training

Palliative care is now a mandatory part of the medical school curriculum for family medicine, internal medicine (of which oncology is a subspecialty), and surgery. In 2006, the American Board of Medical Specialties introduced a palliative care curriculum for those and other subspecialties, including anesthesiology, physical medicine and rehabilitation, pediatrics, radiology, psychiatry and neurology, obstetrics and gynecology, and emergency medicine.

Another program developed with NCI funding, called the Education in Palliative and End-of-Life Care (EPEC) curriculum, is teaching medical students, residents, social workers, and pharmacist throughout California about palliative care. Dr. Michael Wilkes, who led the team that implemented the program statewide at the University of California, said the online program includes four parts: patient stories, tutorials, blogs, and action plans, where students apply what they’ve learned to their own practices and document their competencies.

Dr. Wilkes says the response among students has been overwhelmingly positive. “You know you’ve done a good thing when students are asking for more of it,” he said. “The bottom line is that medical schools way over-focus on disease, and we under-focus on care—of the patient and the family. The end of life is really about care. This online, interactive, case-based curriculum is primarily focused on patients and families addressing such topics as pain control, hospice care, spirituality, ethical and legal issues, and cultural issues at the end of life.”

However, the tool is not all content. “EPEC also acknowledges that we as providers need to take care of ourselves and our colleagues,” Dr. Wilkes explained. “Because providing good care can often take a toll on clinicians, the curriculum helps learners become skilled at understanding and addressing self-care issues and addressing conflicts that arise at the end of life.”

Dr. von Gunten has also gotten positive feedback from his students. “Sometimes they will be on rotation at night, and come in the next morning and tell us, ‘I used your six steps for communication skills, and it was so different.’ That just gives us chills. To have them put it into practice immediately is so fabulous,” he said.

IPM is planning to develop international programs, possibly in Jordan, Mongolia, and the Ukraine. IPM staff will also start tracking U.S. military physician behavior according to palliative care measures, since the military keeps extensive records of physicians’ performance.

Embracing the Art of Healing Medicine

Information on physician behavior will, in turn, help tailor palliative care education programs. To that end, efforts to restore the “art” of healing medicine are actually becoming a science, according to Dr. David Hui of the University of Texas M. D. Anderson Cancer Center, who spoke about palliative care programs in U.S. cancer centers at a JAMA press briefing last week in Washington, DC.

“How do we talk to patients? Sitting down or standing up? These techniques can be taught. I think medical school is where we plant that seed,” said Dr. Hui.

His survey of cancer centers across the country found that fewer than half have fellowship programs for palliative care; of those, only 25 percent have mandatory rotations in palliative care for oncology fellows.

Palliative care education, particularly for oncologists, naturally includes discussions of death, which have not been previously addressed in an in-depth way, said Dr. von Gunten. 

“There is such a thing as normal dying. Many residents have never heard those two words put together,” Dr. von Gunten said, adding that residents have had their most rewarding experiences witnessing and participating in end-of-life care.

“When you routinely see the best in human nature—bravery, altruism—that changes you,” he said, “and gives you renewed enthusiasm about medicine.”

Kristine Crane

Notes

Free Telephone Workshop Series for Cancer Survivors

The eighth annual telephone workshop series, “Living With, Through, and Beyond Cancer,” begins this spring. This four-part series offers cancer survivors, their families and friends, and health care professionals practical information to help them cope with concerns and issues that arise after treatment ends.

The series is presented by CancerCare, in collaboration with NCI, LIVESTRONG, the Intercultural Cancer Council, Living Beyond Breast Cancer, and the National Coalition for Cancer Survivorship.

Part I, which takes place on April 13, is titled “Trouble Sleeping? Sleep Better to Feel Better: Tips You Can Use.” Faculty for this program includes Dr. Elizabeth D. McKinley of Case Western Reserve University, Dr. Sonia Ancoli-Israel of the University of California, San Diego, and Dr. Stewart B. Fleishman of Beth Israel Medical Center and St. Luke's-Roosevelt Hospital.

The workshops are free; no telephone charges apply. To register, visit the CancerCare Web site. All workshops will take place on Tuesdays from 1:30 p.m. to 2:30 p.m. ET. The remaining three workshops will be held on the following dates:

  • Part II: “Communicating with Your Health Care Team After Treatment: Making the Most of Your Visit,” May 18
  • Part III: “Survivorship and Workplace Transitions,” June 22
  • Part IV: “Survivors Too: Communicating With and Among Family, Friends and Loved Ones,” July 13

Print Your Own Copies of Selected NCI Patient Education Booklets

NCI publishes over 180 patient education resources in English and Spanish. You can read these publications online, order printed copies, or print your own booklets. If ordering limits prevent you from receiving enough copies of NCI’s six most popular booklets, there is a new print option available. Contents & Covers allows you to print and assemble a selection of publications when you need them. Available booklets include:

Contents & Covers publications are formatted for easy copying on 8.5x11 inch paper. Print both the cover and the contents of a publication, or print just the contents and order color covers in packs of 25 from NCI. The Contents & Cover option eliminates shipping costs and the need for storage. Printing instructions and information about NCI education materials are available on the NCI Publications Locator Web site.