Clinical trial Recruiting at 44 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment668 (estimated)
SponsorUniversity of Rochester
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations45 sites (Tuscaloosa, Alabama and 44 other locations)
StatusRecruiting
StartedMarch 21, 2023
Main results expectedMay 17, 2027
Study endsSeptember 17, 2027
Registry record updatedJanuary 13, 2026
Trial IDNCT05006482 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.