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

January 10, 2026 updated by: Supriya Mohile, University of Rochester

Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

668

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • Recruiting
        • Lewis and Faye Manderson Cancer Center
        • Principal Investigator:
          • Augusto C. Ochoa
        • Contact:
          • Site Public Contact
          • Phone Number: 800-338-2948
    • California
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
        • Principal Investigator:
          • Valerie Ferguson
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Contact:
        • Principal Investigator:
          • Valerie Ferguson
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
        • Principal Investigator:
          • Valerie Ferguson
      • Honolulu, Hawaii, United States, 96859
        • Recruiting
        • Tripler Army Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-433-6336
        • Principal Investigator:
          • Jeffrey L. Berenberg
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Contact:
        • Principal Investigator:
          • Valerie Ferguson
      • ‘Aiea, Hawaii, United States, 96701
        • Recruiting
        • Pali Momi Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-486-6000
        • Principal Investigator:
          • Valerie Ferguson
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • Sarah E. Jax
    • Missouri
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • New York
      • Dansville, New York, United States, 14437
        • Recruiting
        • Noyes Memorial Hospital/Myers Cancer Center
        • Contact:
        • Principal Investigator:
          • Karen M. Mustian
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Regina A. Jacob
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Karen M. Mustian
      • Rochester, New York, United States, 14620
        • Recruiting
        • Highland Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 585-341-8113
        • Principal Investigator:
          • Karen M. Mustian
      • Rochester, New York, United States, 14623
        • Recruiting
        • Pluta Cancer Center
        • Contact:
        • Principal Investigator:
          • Karen M. Mustian
      • Webster, New York, United States, 14580
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Novant Health Breast Surgery - Greensboro
        • Principal Investigator:
          • Judith O. Hopkins
        • Contact:
      • Kernersville, North Carolina, United States, 27284
        • Recruiting
        • Novant Health Cancer Institute - Kernersville
        • Contact:
        • Principal Investigator:
          • Judith O. Hopkins
      • Mount Airy, North Carolina, United States, 27030
        • Recruiting
        • Novant Health Cancer Institute - Mount Airy
        • Contact:
        • Principal Investigator:
          • Judith O. Hopkins
      • Stateville, North Carolina, United States, 28625
        • Recruiting
        • Novant Health Cancer Institute - Statesville
        • Principal Investigator:
          • Judith O. Hopkins
        • Contact:
      • Thomasville, North Carolina, United States, 27360
        • Recruiting
        • Novant Health Cancer Institute - Thomasville
        • Principal Investigator:
          • Judith O. Hopkins
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Principal Investigator:
          • Judith O. Hopkins
        • Contact:
    • Oklahoma
      • Lindsay, Oklahoma, United States, 73052
        • Recruiting
        • South Central Medical and Resource Center
        • Contact:
          • Site Public Contact
          • Phone Number: 405-756-1414
        • Principal Investigator:
          • Zsolt Nagykaldi
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Nadia N. Ramdin
        • Contact:
      • Scranton, Pennsylvania, United States, 18510
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Nadia N. Ramdin
    • Virginia
      • Chesapeake, Virginia, United States, 23320
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Daisy Boehm
      • Eau Claire, Wisconsin, United States, 54701
        • Suspended
        • HSHS Sacred Heart Hospital
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Brian L. Burnette
        • Contact:
      • Stevens Point, Wisconsin, United States, 54482
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • PRACTICE CRITERIA: Participating practice clusters will be required to identify one (or more) oncologist and/or advanced practice practitioner (APPs; i.e., nurse practitioners, or physician assistants) as part of study eligibility. If another clinician is interested in participating, please contact University of Rochester Cancer 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 from the NCORP practice within one year of enrolling into the study
  • PRACTICE CRITERIA: Support/buy-in from oncology physicians and/or APPs and/or other clinicians who are willing to participate in training and study procedures and enroll cancer survivors
  • ENTRY CRITERIA FOR ONCOLOGY PHYSICIANS/APPS/OTHER CLINICIANS: Oncology physicians/APPs/other clinicians must work at a participating site with no plans to leave that practice or retire within one year of enrollment into the study. We do not require that any or all oncology physicians and/or APPs at a practice setting agree to participate. Only one clinician is required for the practice cluster to be eligible. If another clinician (other than oncology physician or APP) is interested in 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 or lymphoma malignancy in last 6 months. If the survivor is receiving curative-intent chemotherapy, run-in study procedures can occur during the last 6 weeks of chemotherapy.

    • Cancer survivors who will receive or are receiving other treatments (e.g., hormonal treatment, monoclonal antibodies, immunotherapy, radiation) are eligible
    • For patients receiving neoadjuvant chemotherapy for curative intent, the run-in and baseline procedures can occur before or after surgery. Patients should be enrolled within 6 months from the end of surgery
  • CANCER SURVIVORS: Be willing and able to come in for study visits or willing to undergo informed consent and assessments remotely via tele-health visits
  • CANCER SURVIVORS: Be willing and able to provide informed consent and must sign consent in-person or remotely if it is not convenient or feasible to provide informed consent in-person
  • CANCER SURVIVORS: Speak and understand English and/or Spanish. Spanish-speaking cancer survivors are eligible as long as there are appropriate resources in place for completion of study procedures at the practice site. Registration for Spanish-speaking cancer survivors must be approved by the URCC NCORP Research Base after a phone call to determine the feasibility for the practice to enroll a Spanish-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 who can be helpful in health-related matters." A caregiver need not be someone who lives with the cancer survivor or provides direct hands-on care
  • CAREGIVERS: Speak and understand English and/or Spanish. Spanish-speaking caregivers are eligible as long as there are appropriate resources in place for completion of study procedures. Registration for Spanish-speaking caregivers must be approved by the URCC NCORP Research Base after a phone call to determine the feasibility for the practice to enroll a Spanish-speaking participant

Exclusion Criteria:

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

  • CAREGIVERS: Caregivers unable to understand the informed consent form or study procedures due to cognitive, health, or sensory impairment will be excluded

    • Capacity to conduct informed consent procedures and study procedures will be determined by the coordinators in collaboration with the cancer survivors' oncologists. These procedures are similar to that of URCC 13070, which enrolled caregivers of older patients with advanced cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (usual care)
Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive usual follow-up survivorship care
Other Names:
  • standard of care
  • standard therapy
Experimental: Arm II (GEMS intervention)
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 SHE sessions over 75 minutes twice weekly for 4 weeks. Survivors and caregivers also participate in EXCAP program, which includes daily walking and resistance exercises.
Other: Questionnaire Administration
Ancillary studies
Other: Comprehensive Geriatric Assessment
Complete geriatric assessment
Other: Educational Intervention
Participate in survivorship health education sessions
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Procedure: Tailored Intervention
Participate in GEM consultation
Other: Exercise Intervention
Participate in SHE-EXCAP program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported physical function
Time Frame: Up to 6 months
Will be assessed by the Functional Assessment of Cancer Therapy Physical Well-Being (FACIT-PWB) Subscale in older cancer survivors. The FACIT-PWB is 7-items as part of a larger 40-item FACIT-F questionnaire. Each question uses a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much).
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported cognitive function
Time Frame: Up to 6 months
Will be assessed by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) Function in older cancer survivors. The FACT-Cog is a 37-item questionnaire, each with a 5-point Likert scale response. The FACT-Cog provides an overall score and subdomain scores (perceived cognitive impairment [PCI], perceived abilities, comments from others, and impact on quality of life). The secondary aim will be the PCI score at 6 months.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Supriya G Mohile, University of Rochester NCORP Research Base

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

September 17, 2027

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC-19178 (Other Identifier: CTEP)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • NCI-2021-01760 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA249467 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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