Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial

Last updated: January 10, 2026
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Treatment

Tailored Intervention

Exercise Intervention

Educational Intervention

Clinical Study ID

NCT05006482
URCC-19178
UG1CA189961
R01CA249467
NCI-2021-01760
URCC-19178
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This phase III trial compares the effect of geriatric evaluation and management with survivorship health education (GEM-S) 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. GEM-S 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 GEM-S 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:

  • PRACTICE CRITERIA: Participating practice clusters will be required to identify one (or more) oncologist and/or advanced practice practitioner (APPs; i.e., nursepractitioners, or physician assistants) as part of study eligibility. If anotherclinician is interested in participating, please contact University of RochesterCancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) for approval

  • Oncologists/APPs/other clinicians must be licensed to practice

  • Oncologists/APPs/other clinicians must not have a plan to leave or retire fromthe NCORP practice within one year of enrolling into the study

  • PRACTICE CRITERIA: Support/buy-in from oncology physicians and/or APPs and/or otherclinicians who are willing to participate in training and study procedures andenroll cancer survivors

  • ENTRY CRITERIA FOR ONCOLOGY PHYSICIANS/APPS/OTHER CLINICIANS: Oncologyphysicians/APPs/other clinicians must work at a participating site with no plans toleave that practice or retire within one year of enrollment into the study. We donot require that any or all oncology physicians and/or APPs at a practice settingagree to participate. Only one clinician is required for the practice cluster to beeligible. If another clinician (other than oncology physician or APP) is interestedin participating, please contact URCC NCORP RB for approval

  • CANCER SURVIVORS: 65 years or older

  • CANCER SURVIVORS: Have completed or will have completed curative-intent treatment (e.g., surgery, chemotherapy, chemotherapy with radiation) for any solid tumor orlymphoma malignancy in last 6 months. If the survivor is receiving curative-intentchemotherapy, run-in study procedures can occur during the last 6 weeks ofchemotherapy.

  • Cancer survivors who will receive or are receiving other treatments (e.g.,hormonal treatment, monoclonal antibodies, immunotherapy, radiation) areeligible

  • For patients receiving neoadjuvant chemotherapy for curative intent, the run-inand baseline procedures can occur before or after surgery. Patients should beenrolled within 6 months from the end of surgery

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

  • 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 understand English and/or Spanish. Spanish-speakingcancer survivors are eligible as long as there are appropriate resources in placefor completion of study procedures at the practice site. Registration forSpanish-speaking cancer survivors must be approved by the URCC NCORP Research Baseafter a phone call to determine the feasibility for the practice to enroll aSpanish-speaking participant

  • CAREGIVERS: 18 years 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 understand English and/or Spanish. Spanish-speaking caregiversare eligible as long as there are appropriate resources in place for completion ofstudy procedures. Registration for Spanish-speaking caregivers must be approved bythe URCC NCORP Research Base after a phone call to determine the feasibility for thepractice to enroll a Spanish-speaking participant

Exclusion

Exclusion Criteria:

  • 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: 668
Treatment Group(s): 6
Primary Treatment: Tailored Intervention
Phase: 3
Study Start date:
March 21, 2023
Estimated Completion Date:
September 17, 2027

Study Description

PRIMARY OBJECTIVE:

I. To assess the efficacy of GEM-S for improving patient-reported physical function (Functional Assessment of Chronic Illness-Fatigue Physical Well-Being Subscale [FACIT-PWB]) in older cancer survivors at 6 months. (Survivor Aim)

SECONDARY OBJECTIVE:

I. To assess the efficacy of GEM-S for improving patient-reported cognitive function (Functional Assessment of Cancer Therapy [FACT]-cognitive function [Cog]) in older cancer survivors at 6 months.

TERTIARY OBJECTIVES:

I. To assess the preliminary efficacy of GEM-S for improving:

Ia. Objective physical function (6-minute walk test) in older cancer survivors at 6 months; Ib. Objective cognitive function (Objective Cognitive Tests-Trail Making Part A/B [TMT A/B] and Controlled Oral Word Association [COWA] [i.e., FAS Test]) in older cancer survivors at 6 months.

EXPLORATORY HEALTH CARE OBJECTIVES:

I. To explore the preliminary efficacy of GEM-S for improving:

Ia. Survivor satisfaction with care (Health Care Climate Questionnaire [HCCQ] and communication about aging) at 6 months; Ib. Care coordination (# of contacts for co-management) up to 6 months; Ic. Survivor completion of referral appointments (# completed/# referrals) up to 6 months.

EXPLORATORY CAREGIVER OBJECTIVES:

I. To explore the preliminary efficacy of GEM-S for improving:

Ia. Caregiver distress (Distress Thermometer) at 6 months; Ib. Caregiver quality of life (Caregiver Quality of Life Index) at 6 months; Ic. Satisfaction with care (Health Care Climate Questionnaire [HCCQ] and communication about aging) at 6 months.

OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice site.

ARM I: Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.

ARM II: Survivors and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Both survivors and caregivers also participate in survivorship health education (SHE) sessions over 75 minutes twice weekly for 4 weeks. Survivors and caregivers also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.

After completion of study intervention, participants are followed up at 6 months.

Connect with a study center

  • Lewis and Faye Manderson Cancer Center

    Tuscaloosa 4094455, Alabama 4829764 35401
    United States

    Active - Recruiting

  • Kaiser Permanente NCORP (KAISER)

    Vallejo, California 94589
    United States

    Site Not Available

  • Kaiser Permanente-Fremont

    Fremont 5350734, California 5332921 94538
    United States

    Active - Recruiting

  • Kaiser Permanente-San Francisco

    San Francisco 5391959, California 5332921 94115
    United States

    Active - Recruiting

  • Delaware/Christiana Care NCORP (CHRISTIANA)

    Newark, Delaware 19718
    United States

    Site Not Available

  • Helen F Graham Cancer Center

    Newark 4143861, Delaware 4142224 19713
    United States

    Active - Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark 4143861, Delaware 4142224 19713
    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

    Site Not Available

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Active - Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu 5856195, Hawaii 5855797 96826
    United States

    Active - Recruiting

  • Straub Clinic and Hospital

    Honolulu 5856195, Hawaii 5855797 96813
    United States

    Active - Recruiting

  • Tripler Army Medical Center

    Honolulu 5856195, Hawaii 5855797 96859
    United States

    Active - Recruiting

  • Hawaii Cancer Care - Westridge

    ‘Aiea 5856430, Hawaii 5855797 96701
    United States

    Active - Recruiting

  • Pali Momi Medical Center

    ‘Aiea 5856430, Hawaii 5855797 96701
    United States

    Active - Recruiting

  • OSF Saint Anthony's Health Center

    Alton 4232679, Illinois 4896861 62002
    United States

    Active - Recruiting

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Fairview Southdale Hospital

    Edina 5025264, Minnesota 5037779 55435
    United States

    Active - Recruiting

  • Hennepin County Medical Center

    Minneapolis 5037649, Minnesota 5037779 55415
    United States

    Active - Recruiting

  • Monticello Cancer Center

    Monticello 5038045, Minnesota 5037779 55362
    United States

    Active - Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park 5045021, Minnesota 5037779 55416
    United States

    Active - Recruiting

  • Regions Hospital

    Saint Paul 5045360, Minnesota 5037779 55101
    United States

    Active - Recruiting

  • Lakeview Hospital

    Stillwater 5048814, Minnesota 5037779 55082
    United States

    Active - Recruiting

  • Rice Memorial Hospital

    Willmar 5052916, Minnesota 5037779 56201
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury 5053358, Minnesota 5037779 55125
    United States

    Active - Recruiting

  • Lake Regional Hospital

    Osage Beach 4402040, Missouri 4398678 65065
    United States

    Active - Recruiting

  • University of Rochester NCORP Research Base

    Rochester, New York 14642
    United States

    Site Not Available

  • Noyes Memorial Hospital/Myers Cancer Center

    Dansville 5114492, New York 5128638 14437
    United States

    Active - Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success 5123853, New York 5128638 11042
    United States

    Active - Recruiting

  • Highland Hospital

    Rochester 5134086, New York 5128638 14620
    United States

    Active - Recruiting

  • Pluta Cancer Center

    Rochester 5134086, New York 5128638 14623
    United States

    Active - Recruiting

  • University of Rochester

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Wilmot Cancer Institute at Webster

    Webster 5143495, New York 5128638 14580
    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

    Site Not Available

  • Novant Health Breast Surgery - Greensboro

    Greensboro 4469146, North Carolina 4482348 27403
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Kernersville

    Kernersville 4474221, North Carolina 4482348 27284
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Mount Airy

    Mount Airy 4480378, North Carolina 4482348 27030
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Statesville

    Stateville, North Carolina 4482348 28625
    United States

    Active - Recruiting

  • Novant Health Cancer Institute - Thomasville

    Thomasville 4494942, North Carolina 4482348 27360
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • South Central Medical and Resource Center

    Lindsay 4541116, Oklahoma 4544379 73052
    United States

    Active - Recruiting

  • Geisinger Cancer Institute NCORP (GEISINGER)

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville 5186327, Pennsylvania 6254927 17822
    United States

    Active - Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City 5186924, Pennsylvania 6254927 18519
    United States

    Active - Recruiting

  • Community Medical Center

    Scranton 5211303, Pennsylvania 6254927 18510
    United States

    Active - Recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre 5219488, Pennsylvania 6254927 18711
    United States

    Active - Recruiting

  • Chesapeake Regional Medical Center

    Chesapeake 4752186, Virginia 6254928 23320
    United States

    Active - Recruiting

  • Cancer Research of Wisconsin and Northern Michigan Consortium

    Green Bay, Wisconsin 54301
    United States

    Site Not Available

  • Wisconsin NCORP

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • ThedaCare Regional Cancer Center

    Appleton 5244080, Wisconsin 5279468 54911
    United States

    Active - Recruiting

  • HSHS Sacred Heart Hospital

    Eau Claire 5251436, Wisconsin 5279468 54701
    United States

    Suspended

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay 5254962, Wisconsin 5279468 54301
    United States

    Active - Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay 5254962, Wisconsin 5279468 54303
    United States

    Active - Recruiting

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point 5274644, Wisconsin 5279468 54482
    United States

    Active - Recruiting

  • Marshfield Medical Center - Weston

    Weston 5278693, Wisconsin 5279468 54476
    United States

    Active - Recruiting

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