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

Recruiting now · Phase 3

Conditions studied: Lymphoma, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT05006482

Run by

University of Rochester

People needed

668

Starts

2023-03-21

Expected to finish

2027-09-17

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Marshfield Medical Center - Weston — Weston, Wisconsin, United States (enrolling)
• Kaiser Permanente-Fremont — Fremont, California, United States (enrolling)
• Kaiser Permanente-San Francisco — San Francisco, California, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States (enrolling)
• Straub Clinic and Hospital — Honolulu, Hawaii, United States (enrolling)
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (enrolling)
• Tripler Army Medical Center — Honolulu, Hawaii, United States (enrolling)
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States (enrolling)
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States (enrolling)
• OSF Saint Anthony's Health Center — Alton, Illinois, United States (enrolling)
• Fairview Southdale Hospital — Edina, Minnesota, United States (enrolling)
• Hennepin County Medical Center — Minneapolis, Minnesota, United States (enrolling)
• Monticello Cancer Center — Monticello, Minnesota, United States (enrolling)
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States (enrolling)
• Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
• Lakeview Hospital — Stillwater, Minnesota, United States (enrolling)
• Rice Memorial Hospital — Willmar, Minnesota, United States (enrolling)
• Minnesota Oncology Hematology PA-Woodbury — Woodbury, Minnesota, United States (enrolling)
• Lake Regional Hospital — Osage Beach, Missouri, United States (enrolling)
• Noyes Memorial Hospital/Myers Cancer Center — Dansville, New York, United States (enrolling)
• Northwell Health/Center for Advanced Medicine — Lake Success, New York, United States (enrolling)
• Highland Hospital — Rochester, New York, United States (enrolling)
• Pluta Cancer Center — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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