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

RecruitingPhase 3Healthy volunteers welcome

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Full eligibility 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

About the 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.

What is being tested

Sponsor: University of Rochester · Participants: 668 · Started: Mar 21, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05006482

Locations in the U.S.

AlabamaLewis and Faye Manderson Cancer Center, Tuscaloosa
CaliforniaKaiser Permanente-Fremont, Fremont
Kaiser Permanente-San Francisco, San Francisco
DelawareHelen F Graham Cancer Center, Newark
Medical Oncology Hematology Consultants PA, Newark
HawaiiHawaii Cancer Care Inc - Waterfront Plaza, Honolulu
Kapiolani Medical Center for Women and Children, Honolulu
Straub Clinic and Hospital, Honolulu
Tripler Army Medical Center, Honolulu
Hawaii Cancer Care - Westridge, ‘Aiea
Pali Momi Medical Center, ‘Aiea
IllinoisOSF Saint Anthony's Health Center, Alton
MinnesotaFairview Southdale Hospital, Edina
Hennepin County Medical Center, Minneapolis
Monticello Cancer Center, Monticello
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park
Regions Hospital, Saint Paul
Lakeview Hospital, Stillwater
Rice Memorial Hospital, Willmar
Minnesota Oncology Hematology PA-Woodbury, Woodbury
MissouriLake Regional Hospital, Osage Beach
New YorkNoyes Memorial Hospital/Myers Cancer Center, Dansville
Northwell Health/Center for Advanced Medicine, Lake Success
Highland Hospital, Rochester
Pluta Cancer Center, Rochester
University of Rochester, Rochester
Wilmot Cancer Institute at Webster, Webster
North CarolinaNovant Health Breast Surgery - Greensboro, Greensboro
Novant Health Cancer Institute - Kernersville, Kernersville
Novant Health Cancer Institute - Mount Airy, Mount Airy
Novant Health Cancer Institute - Statesville, Stateville
Novant Health Cancer Institute - Thomasville, Thomasville
Novant Health Forsyth Medical Center, Winston-Salem
OklahomaSouth Central Medical and Resource Center, Lindsay
PennsylvaniaGeisinger Medical Center, Danville
Geisinger Cancer Center Dickson City, Dickson City
Community Medical Center, Scranton
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre
VirginiaChesapeake Regional Medical Center, Chesapeake
WisconsinThedaCare Regional Cancer Center, Appleton
Saint Vincent Hospital Cancer Center Green Bay, Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay
Marshfield Medical Center-River Region at Stevens Point, Stevens Point
Marshfield Medical Center - Weston, Weston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.