Geriatric Assessment Intervention for Reducing Chemotherapy Toxicity in Older Patients with Advanced Cancer
- INCLUSION CRITERIA FOR PHYSICIANS
- Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study
- INCLUSION CRITERIA FOR PATIENTS
- Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
- Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if the other agents present a prevalence of toxicity similar to chemotherapy; these therapies can be used in combination with chemotherapy, as a single agent, or in combination with each other * Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (> 50%) will be allowed; a list of allowable agents (single and in combination) meeting this toxicity criteria will be available on the University of Rochester Cancer Center (URCC) NCORP Research Base website as part of the study materials; given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies; if the potentially eligible participant is to receive an approved drug or regimen not on the list, contacting the URCC NCORP Research Base study team is required for approval prior to participant enrollment * Patients who are receiving approved cancer treatment in combination with radiation are eligible * A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
- Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits * The plan for treatment should be for at least 3 months at time of study enrollment; the treatment can stop earlier during the study at the discretion of the physician and patient (e.g., due to progression as noted through imaging, toxicity, or patient preference)
- Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
- Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit; if the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll
- Participant has adequate understanding of the English language
- EXCLUSION CRITERIA FOR PATIENTS
- Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible
- Presence of symptomatic brain metastases at time of study consent process; patients with history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment
Saint Louis Park
New Hyde Park
I. To determine if providing information regarding geriatric assessment (GA) and GA-driven recommendations to oncology physicians reduces clinician-rated grade 3-5 toxicity in patients aged 70 and over with advanced cancer starting a new treatment regimen.
I. Proportion of participants that are alive at 6 months after study entry.
II. Evaluate whether providing oncology physicians with information regarding GA summary and GA-driven recommendations influences clinical care of older patients receiving treatment for advanced cancer.
III. Compare treatment decisions (as measured by relative dose intensity of the agents administered in the first cycle).
IV. Compare the number and type of GA-driven recommendations implemented for older participants starting a new treatment regimen for advanced cancer.
I. To determine whether providing oncology team with GA information and GA-driven recommendations can slow functional and physical decline in older patients with advanced cancer.
II. To examine the association between patient-reported symptoms (as measured by Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE]) and geriatric domains (as measured by geriatric assessment).
III. To compare PRO-CTCAE and physician-rated CTCAE in a sample of older patients receiving chemotherapy or other agents with similar prevalence of toxicity.
IV. To examine the association between PRO-CTCAE and treatment decisions.
V. To examine the association between PRO-CTCAE and adverse outcomes (early discontinuation of chemotherapy, or other agents with similar prevalence of toxicity, hospitalizations, and mortality).
OUTLINE: Treatment sites are randomized to 1 of 2 arms.
ARM I (GA intervention): Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
ARM II (usual care): Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
After completion of study, patients are followed up at 4-6 weeks, at 3 and 6 months, and at 1 year.
Trial Phase Phase I/II
Trial Type Supportive care
University of Rochester NCORP Research Base
Supriya Gupta Mohile
- Primary ID URCC#13059
- Secondary IDs NCI-2013-01904, URCC-13059, URCC-13059, NCT02066168, 13059
- Clinicaltrials.gov ID NCT02054741