Spots Global Cancer Trial Database for Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer
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Trial Identification
Brief Title: Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer
Official Title: Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy
Study ID: NCT05006482
Conditions
Study Description
Brief Summary: This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.
Detailed Description: PRIMARY OBJECTIVE: I. To compare the efficacy of GEMS to usual care for improving patient-reported physical function (Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale \[FACIT-PWB\]) in older cancer survivors at 6 months. SECONDARY OBJECTIVE: I. To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function (FACT-cognitive function \[Cog\]) in older cancer survivors at 6 months. OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice cluster. ARM I: Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months. ARM II: Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks. Patients also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Kaiser Permanente NCORP (KAISER), Vallejo, California, United States
Delaware/Christiana Care NCORP (CHRISTIANA), Newark, Delaware, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Minority Underserved NCORP, Honolulu, Hawaii, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
University of Rochester NCORP Research Base, Rochester, New York, United States
Novant Health Cancer Institute - Kernersville, Winston-Salem, North Carolina, United States
Southeast Clinical Oncology Research Consortium (SCOR), Winston-Salem, North Carolina, United States
Geisinger Cancer Institute NCORP (GEISINGER), Danville, Pennsylvania, United States
Cancer Research of Wisconsin and Northern Michigan Consortium, Green Bay, Wisconsin, United States
Wisconsin NCORP, Marshfield, Wisconsin, United States
Contact Details
Name: Supriya G Mohile
Affiliation: University of Rochester NCORP Research Base
Role: PRINCIPAL_INVESTIGATOR
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