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Minimize Cancer Treatment’s Debilitating Side Effects

NCI has announced several funding opportunities that align with the Cancer Moonshot.

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Cancer patients often experience unpleasant side effects that can contribute to lower health-related quality of life, lead to costly emergency visits to the hospital, and cause treatment delays or non-adherence to a therapy.

Poorly controlled symptoms increase risks for poor outcomes and the likelihood of a patient not being able to return to work. Also, patients from racial/ethnic minority groups, older age groups, and underserved populations often experience mismanaged symptom control, have significant delays in--or stop adhering to--treatment, and have limited access to symptom management approaches.

Helping patients manage intolerable side effects and improving their functioning may support the likelihood that they will adhere to treatments that are effective. Successful symptom management will require the systematic gathering of patient-reported outcomes data and evidence-based symptom management data for patients from diverse populations.

This recommendation supports the development of research to accelerate the implementation of guidelines for routine monitoring and management of patient-reported symptoms in all populations. Such research includes the examination of patient-reported symptoms and the support of intervention studies to determine the best approaches for symptom control and supportive care for cancer patients in routine clinical practice. Since patients at different points on the cancer continuum have a variety of needs, research will investigate patients’ symptoms and functioning from diagnosis through survivorship or end-of-life, and will include patients throughout the course of their lives.

The ultimate goal of symptom management research supported by this recommendation is to reduce harmful symptoms experienced by cancer patients and decrease cancer care costs related to poorly controlled symptoms.

Currently, NCI has awarded funding opportunities that align with the recommendation to address treatment side effects:

Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability

NCI has created a consortium of multidisciplinary teams that is developing new methods for analyzing patient-reported outcomes in the setting of cancer clinical trials to better define patient tolerability. Researchers in the consortium are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), other patient-reported outcome (PRO) data, and clinical data for their analyses. This information will help researchers, clinicians, and patients understand the symptomatic side effects of cancer treatments. The multidisciplinary teams of data scientists, clinical researchers, and experts in patient-reported data are addressing current limitations of clinician-reported adverse events, analysis of symptoms at baseline, and methods to display/communicate adverse event data.

Projects in the network are leveraging patient-reported data from existing trials and seek to establish a proof-of-principle for analyzing and interpreting PRO-CTCAE data. Findings from this network will shed light on the degree to which patients tolerate different cancer treatments.

Translation and Validation of Patient-Reported Outcome (PRO) Measures to Address an Accrual Barrier to Minority and Underserved Participation in Symptom Clinical Trials

Endpoints in symptom management clinical trials are mainly appraised using PRO measures; however, many symptom-specific PRO measures are neither widely available in, nor culturally adapted for, languages other than English. The NCI Community Oncology Research Program (NCORP) identified the lack of translated PROs as a significant barrier for the participation of non-English and low-English speaking patients within minority and underserved populations in symptom management trials.

To address the current language barrier that limits participation in symptom management trials, this initiative will support the translation, validation, and cultural adaptation of PRO measures into multiple languages. NCORP investigators will identify commonly used PRO measures in their symptom management trials that are currently not available to non-English and low-English speaking patients. These PROs will be translated into languages other than English identified by the NCORP sites. By translating PRO measures, this project aims to improve symptom care for non-English speaking and low-English proficient cancer patients and cancer survivors, as well as to enhance the diversity of patients participating in symptom management trials.

Improving the Management of symPtoms during and following Cancer Treatment (IMPACT)

This collaborative research consortium is implementing and evaluating systematic symptom management in cancer care delivery to improve symptom control for cancer patients during and following treatment. The consortium consists of three individual Research Centers (RCs) that are deploying integrated electronic systems to monitor and manage cancer symptoms in diverse practice settings, as well as a Coordinating Center (CC) that provides scientific expertise and logistical support to unite the consortium. The three RCs within the IMPACT Consortium are deploying integrated symptom monitoring and management systems in diverse clinical practices and testing the effects of those systems on patient outcomes, cancer treatment delivery, and healthcare utilization. The IMPACT Coordinating Center supports Consortium-wide logistics and research activities, including standardized protocols and data sharing.

The aim of the IMPACT initiative is to set the foundation for effective, scalable, and sustainable symptom management approaches in routine cancer care. Pragmatic trials conducted through the IMPACT Consortium are determining the best models for implementing symptom management approaches, understanding the utility of using systems to reduce the harmful effects of poorly controlled symptoms in cancer patients, and building a foundation for the development of effective symptom management tools in routine clinical care. The IMPACT Consortium, leveraging research at RCs and their clinical practices, uses implementation science to help accelerate the adoption of systematic approaches that can improve symptom management for cancer patients and survivors across the United States.

More information about the consortium can be found at the IMPACT Consortium website.

Improving Outcomes for Pediatric, Adolescent and Young Adult (AYA) Cancer Survivors

The NCI Surveillance, Epidemiology, and End Results (SEER) Program estimates that there are more than 630,000 cancer survivors between the ages 0 to 39 in the United States. Studies suggest that over 60% of these cancer survivors will suffer from physical, psychosocial, or behavioral side effects related to their disease or treatment, even years after the completion of therapy. These adverse effects can significantly impair survival and quality of life outcomes for Pediatric, Adolescent and Young Adult (AYA) cancer survivors.

Research projects focused on improving outcomes for AYA cancer survivors are developing interventions to prevent, mitigate, and manage adverse, long-term disease- and treatment-related adverse effects for survivors of pediatric and AYA cancers across their lifespans. Investigators are also examining approaches to improve the delivery of cancer care to diverse pediatric and AYA cancer survivors, including minority and medically underserved populations. This program aims to reduce the harmful, adverse physical, behavioral, and psychosocial effects in survivors of these specific cancers.

Additionally, this Cancer Moonshot program is supported by the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act, a bipartisan childhood cancer bill designed to advance pediatric and AYA cancer research and treatments, improve cancer surveillance, and enhance resources for survivors and their families.

Graft-Versus-Host Disease (GVHD) Symptom Management

Chronic graft-versus-host disease (GVHD) is a major complication that can occur after hematopoietic stem cell transplantation, a therapy often used to treat blood cancers. In GVHD, the stem cells from a donor (or the graft) attack the healthy tissues of the recipient patient (or host). GVHD produces multi-system organ complications that often mimic autoimmune conditions, resulting in significant disability and symptom burden. Currently, there is no pediatric patient-reported outcome measure of chronic GVHD symptoms. Researchers with NCI’s Center for Cancer Research (CCR) and Outcomes Research Branch (ORB) are conducting a two-phase study to refine and validate a pediatric chronic GVHD symptom scale (PCSS). This new measure will improve the way that chronic GVHD symptoms are evaluated and managed in children and adolescents ages 5 to 17.

Researchers are also developing a companion measure that can be completed by a parent-proxy. This study will yield a well-validated measure for use in children and adolescents with GVHD. This new pediatric measure can be integrated into clinical trials and care delivery for pediatric transplant survivors to improve the precision and accuracy with which their GVHD symptom experience is captured. Ultimately, this study will provide new tools and insights that can be used to accelerate research to prevent, mitigate, and manage chronic GVHD, thereby improving outcomes for pediatric and adolescent cancer survivors.

Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care

In 2016, there were an estimated 15.5 million cancer survivors in the United States, and this number is projected to grow to over 26 million survivors by 2040. Further, the transition from active treatment to posttreatment follow-up care is a critical period for cancer survivors. During this time, cancer survivors often experience a loss of their safety net and frequently have unique posttreatment needs, including monitoring for recurrence and second cancers, mitigating chronic or late effects of cancer and its treatment, and managing comorbid conditions. Thus, cancer survivors need the delivery of comprehensive, coordinated, and continuing care after the completion of treatment.

Research Projects funded through the Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care program are developing and/or scaling-up innovative and effective multi-level interventions that improve the delivery of post-treatment follow-up care and outcomes for survivors of adult cancers. Specifically, these projects are designing and testing approaches for follow-up care that enhance communication, collaboration, and coordination among different clinicians involved in the transition of a broad spectrum of adult cancer survivors from treatment to follow up care.

Projects Awarded Cancer Moonshot Funding to Address Symptom Management

Awarded Projects
Funding Opportunity Project Title Institution Principal Investigator(s)
Analyzing and Interpreting Clinician and Patient Adverse Event Data to Better Understand Tolerability (U01) Analyzing and Interpreting PRO-CTCAE with CTCAE and Other Clinical Data to Characterize Drug Tolerability University of North Carolina at Chapel Hill Basch, Ethan M; Dueck, Amylou C
Analysis of ECOG-ACRIN Adverse Event Data to Optimize Strategies for the Longitudinal Assessment of Tolerability in the Context of Evolving Cancer Treatment Paradigms (EVOLV) Dana-Farber Cancer Institute Gray, Robert J; Wagner, Lynne I
Understanding Treatment Tolerability in Older Patients with Cancer University of Rochester Mohile, Supriya G
Advancing Analysis and Interpretation of Adverse Events and PROs in Cancer Clinical Trials Cedars-Sinai Medical Center Rogatko, Andre; Ganz, Patricia A
Research Centers for Improving Management of Symptoms Across Cancer Treatments (IMPACT) (UM1)/td> Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program across a Multi-site, Fully-integrated Comprehensive Cancer Center Northwestern University Cella, David
Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) Pragmatic Clinical Trial Mayo Clinic Rochester Chebille, Andrea Lynne
SIMPRO Research Center: Integration and Implementation of PROs for Symptom Management in Oncology Practice Dana-Farber Cancer Institute Schrag, Deborah; Osarogiagbon, Raymond U; Wong, Sandra L
Coordinating Center for Improving Management of Symptoms Across Cancer Treatments (IMPACT) (U24) Coordinating Center for Research Centers for Improving Management of Symptoms During and Following Cancer Treatment Research Triangle Institute Kroner, Barbara L
Improving Outcomes for Pediatric, 
Adolescent and Young Adult Cancer Survivors (U01 Clinical Trial Required)
A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors Yale University Kadan-Lottick, Nina S; Mendoza, Jason A
Utility of memantine in preventing cognitive dysfunction in children receiving cranial radiotherapy Mayo Clinic Rochester Laack, Nadia N
Using Information Technology to Improve Outcomes for Children Living with Cancer Northwestern University At Chicago Lai, Jin-Shei 
Optimizing the Management and Outcomes for Cancer Survivors Transitioning to Follow-up Care (R01) Technology-Enabled Activation of Skin Cancer Screening for Hematopoietic Cell Transplantation Survivors and their Primary Care Providers Beckman Research Institute/City of Hope Armenian, Saro; Geller, Alan Charles
The EPICS (Engaging Primary Care In Cancer Survivorship) Study: A Randomized Trial of Novel Models of Care for Cancer Survivors Kaiser Foundation Research Institute Hahn, Erin Elizabeth
Optimizing Functional Outcomes of Older Survivors After Chemotherapy University of Rochester Mohile, Supriya G; Janelsins, Michelle C; Mustian, Karen M
Onco-Primary Care Networking to Support Team-Based Care – The One Team Study Duke University Oeffinger, Kevin Charles; Zullig, Leah L
Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancer Beckman Research Institute/City of Hope Sun, Virginia Chih-Yi
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