Geriatric evaluation and management program for older cancer survivors
Official title: Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
Run by University of Rochester · NCT05006482 · Data updated 2026-11-12
This study is testing if a special program that combines health education and support can help older cancer survivors feel better and improve their daily life after finishing chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 668 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 45 sites (Tuscaloosa, Alabama and 44 other locations) |
| Status | Recruiting |
| Started | March 21, 2023 |
| Main results expected | May 17, 2027 |
| Study ends | September 17, 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT05006482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are cancer survivors aged 65 and older who have completed curative-intent chemotherapy for solid tumors within the last six months.
✕Probably not a fit
Patients who are not cancer survivors or those who have not undergone recent chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a geriatric evaluation and management program combined with survivorship health education (GEMS) compared to standard care for older cancer survivors. Participants will be randomly assigned to receive either usual care or the GEMS intervention, which includes consultations and educational sessions aimed at improving physical and cognitive functions. The study focuses on assessing patient-reported outcomes related to physical function and cognitive health over a six-month period. The goal is to determine if GEMS can enhance the quality of life for older adults who have recently completed chemotherapy for solid tumors.
Why it matters
Potential benefit: If successful, this program could significantly improve the physical and cognitive well-being of older cancer survivors.
How similar studies have gone: Previous studies have shown promising results with similar geriatric interventions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, United States Recruiting -
Kaiser Permanente-Fremont
Fremont, California, United States Recruiting -
Kaiser Permanente-San Francisco
San Francisco, California, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States Recruiting
Show 39 more locations
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Straub Clinic and Hospital
Honolulu, Hawaii, United States Recruiting -
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States Recruiting -
Tripler Army Medical Center
Honolulu, Hawaii, United States Recruiting -
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States Recruiting -
Pali Momi Medical Center
‘Aiea, Hawaii, United States Recruiting -
OSF Saint Anthony's Health Center
Alton, Illinois, United States Recruiting -
Fairview Southdale Hospital
Edina, Minnesota, United States Recruiting -
Hennepin County Medical Center
Minneapolis, Minnesota, United States Recruiting -
Monticello Cancer Center
Monticello, Minnesota, United States Recruiting -
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States Recruiting -
Regions Hospital
Saint Paul, Minnesota, United States Recruiting -
Lakeview Hospital
Stillwater, Minnesota, United States Recruiting -
Rice Memorial Hospital
Willmar, Minnesota, United States Recruiting -
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States Recruiting -
Lake Regional Hospital
Osage Beach, Missouri, United States Recruiting -
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, United States Recruiting -
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States Recruiting -
Highland Hospital
Rochester, New York, United States Recruiting -
Pluta Cancer Center
Rochester, New York, United States Recruiting -
University of Rochester
Rochester, New York, United States Recruiting -
Wilmot Cancer Institute at Webster
Webster, New York, United States Recruiting -
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, United States Recruiting -
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, United States Recruiting -
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, United States Recruiting -
Novant Health Cancer Institute - Statesville
Stateville, North Carolina, United States Recruiting -
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, United States Recruiting -
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States Recruiting -
South Central Medical and Resource Center
Lindsay, Oklahoma, United States Recruiting -
Geisinger Medical Center
Danville, Pennsylvania, United States Recruiting -
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States Recruiting -
Community Medical Center
Scranton, Pennsylvania, United States Recruiting -
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States Recruiting -
Chesapeake Regional Medical Center
Chesapeake, Virginia, United States Recruiting -
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States Recruiting -
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States Recruiting -
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States Recruiting -
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States Recruiting -
Marshfield Medical Center - Weston
Weston, Wisconsin, United States Recruiting -
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, United States Suspended
Study contacts
- Principal investigator: Supriya G Mohile — University of Rochester NCORP Research Base
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.