Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
NCT ID: NCT05006482
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
668 participants
INTERVENTIONAL
2023-03-21
2027-09-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Best Practice
Receive usual follow-up survivorship care
Questionnaire Administration
Ancillary studies
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.
Comprehensive Geriatric Assessment
Complete geriatric assessment
Educational Intervention
Participate in survivorship health education sessions
Exercise Intervention
Participate in SHE-EXCAP program
Questionnaire Administration
Ancillary studies
Tailored Intervention
Participate in GEM consultation
Interventions
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Best Practice
Receive usual follow-up survivorship care
Comprehensive Geriatric Assessment
Complete geriatric assessment
Educational Intervention
Participate in survivorship health education sessions
Exercise Intervention
Participate in SHE-EXCAP program
Questionnaire Administration
Ancillary studies
Tailored Intervention
Participate in GEM consultation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Supriya Mohile
URCC Study Chair
Principal Investigators
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Supriya G Mohile
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
Highland Hospital
Rochester, New York, United States
Pluta Cancer Center
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Wilmot Cancer Institute at Webster
Webster, New York, United States
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, United States
Novant Health Cancer Institute - Statesville
Stateville, North Carolina, United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
South Central Medical and Resource Center
Lindsay, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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References
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Yilmaz S, Janelsins MC, Flannery M, Culakova E, Wells M, Lin PJ, Loh KP, Epstein R, Kamen C, Kleckner AS, Norton SA, Plumb S, Alberti S, Doyle K, Porto M, Weber M, Dukelow N, Magnuson A, Kehoe LA, Nightingale G, Jensen-Battaglia M, Mustian KM, Mohile SG. Protocol paper: Multi-site, cluster-randomized clinical trial for optimizing functional outcomes of older cancer survivors after chemotherapy. J Geriatr Oncol. 2022 Jul;13(6):892-903. doi: 10.1016/j.jgo.2022.03.001. Epub 2022 Mar 12.
Other Identifiers
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NCI-2021-01760
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC-19178
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-19178
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-19178
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-19178
Identifier Type: -
Identifier Source: org_study_id
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