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Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
NCT05006482 · University of Rochester
In plain English
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Official title
Optimizing Functional Outcomes of Older Cancer Survivors: The GEM-S Study
About this study
PRIMARY OBJECTIVE:
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.
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
Study design
Enrollment target: 668 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-03-21
Estimated completion: 2027-09-17
Last updated: 2026-01-13
Interventions
Other: Best PracticeOther: Comprehensive Geriatric AssessmentOther: Educational InterventionOther: Exercise InterventionOther: Questionnaire AdministrationProcedure: Tailored Intervention
Primary outcomes
- • Patient-reported physical function (Up to 6 months)
Sponsor
University of Rochester · other
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorSupriya G Mohile · principal_investigator, University of Rochester NCORP Research Base
All locations (45)
Lewis and Faye Manderson Cancer CenterRecruiting
Tuscaloosa, Alabama, United States
Kaiser Permanente-FremontRecruiting
Fremont, California, United States
Kaiser Permanente-San FranciscoRecruiting
San Francisco, California, United States
Helen F Graham Cancer CenterRecruiting
Newark, Delaware, United States
Medical Oncology Hematology Consultants PARecruiting
Newark, Delaware, United States
Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
Honolulu, Hawaii, United States
Straub Clinic and HospitalRecruiting
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and ChildrenRecruiting
Honolulu, Hawaii, United States
Tripler Army Medical CenterRecruiting
Honolulu, Hawaii, United States
Hawaii Cancer Care - WestridgeRecruiting
‘Aiea, Hawaii, United States
Pali Momi Medical CenterRecruiting
‘Aiea, Hawaii, United States
OSF Saint Anthony's Health CenterRecruiting
Alton, Illinois, United States
Fairview Southdale HospitalRecruiting
Edina, Minnesota, United States
Hennepin County Medical CenterRecruiting
Minneapolis, Minnesota, United States
Monticello Cancer CenterRecruiting
Monticello, Minnesota, United States
Park Nicollet Clinic - Saint Louis ParkRecruiting
Saint Louis Park, Minnesota, United States
Regions HospitalRecruiting
Saint Paul, Minnesota, United States
Lakeview HospitalRecruiting
Stillwater, Minnesota, United States
Rice Memorial HospitalRecruiting
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-WoodburyRecruiting
Woodbury, Minnesota, United States
Lake Regional HospitalRecruiting
Osage Beach, Missouri, United States
Noyes Memorial Hospital/Myers Cancer CenterRecruiting
Dansville, New York, United States
Northwell Health/Center for Advanced MedicineRecruiting
Lake Success, New York, United States
Highland HospitalRecruiting
Rochester, New York, United States
Pluta Cancer CenterRecruiting
Rochester, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
Wilmot Cancer Institute at WebsterRecruiting
Webster, New York, United States
Novant Health Breast Surgery - GreensboroRecruiting
Greensboro, North Carolina, United States
Novant Health Cancer Institute - KernersvilleRecruiting
Kernersville, North Carolina, United States
Novant Health Cancer Institute - Mount AiryRecruiting
Mount Airy, North Carolina, United States
Novant Health Cancer Institute - StatesvilleRecruiting
Stateville, North Carolina, United States
Novant Health Cancer Institute - ThomasvilleRecruiting
Thomasville, North Carolina, United States
Novant Health Forsyth Medical CenterRecruiting
Winston-Salem, North Carolina, United States
South Central Medical and Resource CenterRecruiting
Lindsay, Oklahoma, United States
Geisinger Medical CenterRecruiting
Danville, Pennsylvania, United States
Geisinger Cancer Center Dickson CityRecruiting
Dickson City, Pennsylvania, United States
Community Medical CenterRecruiting
Scranton, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
Wilkes-Barre, Pennsylvania, United States
Chesapeake Regional Medical CenterRecruiting
Chesapeake, Virginia, United States
ThedaCare Regional Cancer CenterRecruiting
Appleton, Wisconsin, United States
HSHS Sacred Heart HospitalSuspended
Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green BayRecruiting
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
Green Bay, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens PointRecruiting
Stevens Point, Wisconsin, United States
Marshfield Medical Center - WestonRecruiting
Weston, Wisconsin, United States