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

NCT05006482 | Recruiting Phase 3 DMC

• 4 other identifiers: URCC-19178NCI-2021-01760R01CA249467UG1CA189961
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 45

Brief Summary

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.

Conditions

Lymphoma; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Patient-reported physical function

  Will be assessed by the Functional Assessment of Cancer Therapy Physical Well-Being (FACIT-PWB) Subscale in older cancer survivors. The FACIT-PWB is 7-items as part of a larger 40-item FACIT-F questionnaire. Each question uses a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much).

  Up to 6 months

Secondary Outcomes (1)

• Patient-reported cognitive function

  Up to 6 months

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

Survivors and caregivers receive routine survivorship follow-up care at their doctor's office for 3 visits over 6 months on study.

Other: Best Practice; Other: Questionnaire Administration

Arm II (GEMS intervention)

EXPERIMENTAL

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.

Other: Comprehensive Geriatric Assessment; Other: Educational Intervention; Other: Exercise Intervention; Other: Questionnaire Administration; Procedure: Tailored Intervention

Interventions

Best Practice OTHER

Receive usual follow-up survivorship care

Also known as: standard of care, standard therapy

Arm I (usual care)

Comprehensive Geriatric Assessment OTHER

Complete geriatric assessment

Arm II (GEMS intervention)

Educational Intervention OTHER

Participate in survivorship health education sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (GEMS intervention)

Exercise Intervention OTHER

Participate in SHE-EXCAP program

Arm II (GEMS intervention)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (GEMS intervention)

Tailored Intervention PROCEDURE

Participate in GEM consultation

Arm II (GEMS intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (45)

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama, 35401, United States

RECRUITING

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

RECRUITING

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

RECRUITING

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

RECRUITING

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Monticello Cancer Center

Monticello, Minnesota, 55362, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

Lakeview Hospital

Stillwater, Minnesota, 55082, United States

RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, 56201, United States

RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

Noyes Memorial Hospital/Myers Cancer Center

Dansville, New York, 14437, United States

RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

RECRUITING

Highland Hospital

Rochester, New York, 14620, United States

RECRUITING

Pluta Cancer Center

Rochester, New York, 14623, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, 14580, United States

RECRUITING

Novant Health Breast Surgery - Greensboro

Greensboro, North Carolina, 27403, United States

RECRUITING

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina, 27284, United States

RECRUITING

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina, 27030, United States

RECRUITING

Novant Health Cancer Institute - Statesville

Stateville, North Carolina, 28625, United States

RECRUITING

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina, 27360, United States

RECRUITING

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

South Central Medical and Resource Center

Lindsay, Oklahoma, 73052, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Geisinger Cancer Center Dickson City

Dickson City, Pennsylvania, 18519, United States

RECRUITING

Community Medical Center

Scranton, Pennsylvania, 18510, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Chesapeake Regional Medical Center

Chesapeake, Virginia, 23320, United States

RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

RECRUITING

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

SUSPENDED

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35292232 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

Practice Guidelines as Topic; Standard of Care; Geriatric Assessment; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Epidemiologic Measurements; Public Health; Environment and Public Health; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors

Study Officials

• Supriya G Mohile

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: URCC Study Chair

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: March 21, 2023
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): September 17, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (45)