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Geriatric Evaluation and Management With Survivorship Health Education (GEMS) for Older Survivors of Cancer

Malignant Solid Neoplasm Clinical Trial

Official title:
Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05006482
Study type Interventional
Source University of Rochester
Contact Caitlyn Hoffman
Phone 585-274-0487
Email URCC_19178@URMC.Rochester.edu
Status Recruiting
Phase N/A
Start date July 18, 2023
Completion date December 31, 2028
View Details
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