New study tests program to boost daily function in older cancer survivors
NCT ID NCT05006482
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether a program called GEM-S (geriatric evaluation and management with survivorship health education) can improve physical function in older cancer survivors. About 668 participants who have completed chemotherapy for lymphoma or solid tumors will be randomly assigned to GEM-S or usual care. The program includes a geriatric assessment, tailored health advice, and exercise sessions, aiming to help survivors maintain their ability to perform daily activities and improve mental well-being.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Geriatric evaluation and management plus survivorship health education (GEM-S)
- What this could lead to
- If successful, this could lead to a standard program that helps older cancer survivors maintain their physical abilities, mental sharpness, and quality of life after chemotherapy.
- What could go wrong
- This is a large phase 3 trial, but the intervention is complex and may not work better than usual care. Results depend on how well participants follow the program, and benefits may vary widely.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 668 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
45 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
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Locations
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Chesapeake Regional Medical Center
RECRUITINGChesapeake, Virginia, 23320, United States
Contact Email: •••••@•••••
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Community Medical Center
RECRUITINGScranton, Pennsylvania, 18510, United States
Contact Email: •••••@•••••
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Fairview Southdale Hospital
RECRUITINGEdina, Minnesota, 55435, United States
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Geisinger Cancer Center Dickson City
RECRUITINGDickson City, Pennsylvania, 18519, United States
Contact Email: •••••@•••••
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Geisinger Medical Center
RECRUITINGDanville, Pennsylvania, 17822, United States
Contact Email: •••••@•••••
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Geisinger Wyoming Valley/Henry Cancer Center
RECRUITINGWilkes-Barre, Pennsylvania, 18711, United States
Contact Email: •••••@•••••
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HSHS Sacred Heart Hospital
SUSPENDEDEau Claire, Wisconsin, 54701, United States
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Hawaii Cancer Care - Westridge
RECRUITING‘Aiea, Hawaii, 96701, United States
Contact Email: •••••@•••••
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Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITINGHonolulu, Hawaii, 96813, United States
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Helen F Graham Cancer Center
RECRUITINGNewark, Delaware, 19713, United States
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Hennepin County Medical Center
RECRUITINGMinneapolis, Minnesota, 55415, United States
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Highland Hospital
RECRUITINGRochester, New York, 14620, United States
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Kaiser Permanente-Fremont
RECRUITINGFremont, California, 94538, United States
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Kaiser Permanente-San Francisco
RECRUITINGSan Francisco, California, 94115, United States
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Kapiolani Medical Center for Women and Children
RECRUITINGHonolulu, Hawaii, 96826, United States
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Lake Regional Hospital
RECRUITINGOsage Beach, Missouri, 65065, United States
Contact Email: •••••@•••••
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Lakeview Hospital
RECRUITINGStillwater, Minnesota, 55082, United States
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Lewis and Faye Manderson Cancer Center
RECRUITINGTuscaloosa, Alabama, 35401, United States
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Marshfield Medical Center - Weston
RECRUITINGWeston, Wisconsin, 54476, United States
Contact Email: •••••@•••••
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Marshfield Medical Center-River Region at Stevens Point
RECRUITINGStevens Point, Wisconsin, 54482, United States
Contact Email: •••••@•••••
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Medical Oncology Hematology Consultants PA
RECRUITINGNewark, Delaware, 19713, United States
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Minnesota Oncology Hematology PA-Woodbury
RECRUITINGWoodbury, Minnesota, 55125, United States
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Monticello Cancer Center
RECRUITINGMonticello, Minnesota, 55362, United States
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Northwell Health/Center for Advanced Medicine
RECRUITINGLake Success, New York, 11042, United States
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Novant Health Breast Surgery - Greensboro
RECRUITINGGreensboro, North Carolina, 27403, United States
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Novant Health Cancer Institute - Kernersville
RECRUITINGKernersville, North Carolina, 27284, United States
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Novant Health Cancer Institute - Mount Airy
RECRUITINGMount Airy, North Carolina, 27030, United States
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Novant Health Cancer Institute - Statesville
RECRUITINGStateville, North Carolina, 28625, United States
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Novant Health Cancer Institute - Thomasville
RECRUITINGThomasville, North Carolina, 27360, United States
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Novant Health Forsyth Medical Center
RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Noyes Memorial Hospital/Myers Cancer Center
RECRUITINGDansville, New York, 14437, United States
Contact Email: •••••@•••••
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OSF Saint Anthony's Health Center
RECRUITINGAlton, Illinois, 62002, United States
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Pali Momi Medical Center
RECRUITING‘Aiea, Hawaii, 96701, United States
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Park Nicollet Clinic - Saint Louis Park
RECRUITINGSaint Louis Park, Minnesota, 55416, United States
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Pluta Cancer Center
RECRUITINGRochester, New York, 14623, United States
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Regions Hospital
RECRUITINGSaint Paul, Minnesota, 55101, United States
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Rice Memorial Hospital
RECRUITINGWillmar, Minnesota, 56201, United States
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Saint Vincent Hospital Cancer Center Green Bay
RECRUITINGGreen Bay, Wisconsin, 54301, United States
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Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITINGGreen Bay, Wisconsin, 54303, United States
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South Central Medical and Resource Center
RECRUITINGLindsay, Oklahoma, 73052, United States
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Straub Clinic and Hospital
RECRUITINGHonolulu, Hawaii, 96813, United States
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ThedaCare Regional Cancer Center
RECRUITINGAppleton, Wisconsin, 54911, United States
Contact Email: •••••@•••••
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Tripler Army Medical Center
RECRUITINGHonolulu, Hawaii, 96859, United States
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University of Rochester
RECRUITINGRochester, New York, 14642, United States
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Wilmot Cancer Institute at Webster
RECRUITINGWebster, New York, 14580, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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