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

Last updated: February 13, 2025
Sponsor: University of Rochester NCORP Research Base
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Tailored Intervention

Educational Intervention

Best Practice

Clinical Study ID

NCT05006482
URCC-19178
UG1CA189961
R01CA249467
NCI-2021-01760
URCC-19178
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CANCER SURVIVORS: 65 years of age or older

  • CANCER SURVIVORS: Have completed or will have completed curative-intent adjuvantchemotherapy for any solid tumor malignancy in last 6 months. Run-in studyprocedures can occur during the last 4 weeks of adjuvant chemotherapy but must becompleted no later than 6 months after the completion of adjuvant chemotherapy.Cancer survivors who will receive other curative-intent treatments (e.g., hormonaltreatment, monoclonal antibodies, radiation) other than surgery are eligible

  • CANCER SURVIVORS: Be willing and able to come in for study visits or willing toundergo informed consent and assessments remotely via tele-health visits whennecessary

  • CANCER SURVIVORS: Be willing and able to provide informed consent and must signconsent in-person or remotely if it is not convenient or feasible to provideinformed consent in-person

  • CANCER SURVIVORS: Speak and read English and/or Spanish. Spanish-speaking cancersurvivors are eligible as long as there are appropriate resources in place forcompletion of study procedures at the practice site. Registration forSpanish-speaking cancer survivors must be approved by the University of RochesterCancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base

  • CAREGIVERS: 18 years of age or older

  • CAREGIVERS: Selected by the cancer survivor when asked if there is a "family member,partner, friend or caregiver (age 18 years or older) with whom you discuss or whocan be helpful in health-related matters." A caregiver need not be someone who liveswith the cancer survivor or provides direct hands-on care

  • CAREGIVERS: Speak and read English and/or Spanish. Spanish-speaking caregivers areeligible as long as there are appropriate resources in place for completion of studyprocedures. Registration for Spanish-speaking caregivers must be approved by theURCC NCORP Research Base

Exclusion

Exclusion Criteria:

  • CANCER SURVIVORS: Have surgery planned within six months of informed consent. Cancersurvivors who previously had surgery are eligible

  • CANCER SURVIVORS: Have a condition that precludes their ability to participate ininformed consent or procedures (e.g., dementia)

  • CAREGIVERS: Caregivers unable to understand the informed consent form or studyprocedures due to cognitive, health, or sensory impairment will be excluded.Capacity to conduct informed consent procedures and study procedures will bedetermined by the coordinators in collaboration with the cancer survivors'oncologists. These procedures are similar to that of URCC 13070, which enrolledcaregivers of older patients with advanced cancer.

Study Design

Total Participants: 960
Treatment Group(s): 6
Primary Treatment: Tailored Intervention
Phase:
Study Start date:
July 18, 2023
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Kaiser Permanente NCORP (KAISER)

    Vallejo, California 94589
    United States

    Active - Recruiting

  • Delaware/Christiana Care NCORP (CHRISTIANA)

    Newark, Delaware 19718
    United States

    Active - Recruiting

  • Hawaii Minority Underserved NCORP

    Honolulu, Hawaii 96822
    United States

    Active - Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • University of Rochester NCORP Research Base

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Kernersville

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Southeast Clinical Oncology Research Consortium (SCOR)

    Winston-Salem, North Carolina 27104
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Geisinger Cancer Institute NCORP (GEISINGER)

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Cancer Research of Wisconsin and Northern Michigan Consortium

    Green Bay, Wisconsin 54301
    United States

    Active - Recruiting

  • Wisconsin NCORP

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.