Recruiting

Phase 3

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

Sponsor:

University of Rochester

Code:

NCT05006482

Conditions

Lymphoma

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Best Practice

Comprehensive Geriatric Assessment

Educational Intervention

Exercise Intervention

Questionnaire Administration

Study Details

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

Study ID

NCT05006482

Start date

Mar 21, 2023

Status verified date

Jan, 2026

Completion date

Sep 17, 2027

Anticipated

Primary completion date

May 17, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

668 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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

Primary outcome measure

Patient-reported physical function [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Locations

Lewis and Faye Manderson Cancer Center

Recruiting

Tuscaloosa, Alabama, United States, 35401

Contacts

Site Public Contact

800-338-2948

Principal Investigator:

Augusto C. Ochoa

Kaiser Permanente-Fremont

Recruiting

Fremont, California, United States, 94538

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Kaiser Permanente-San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Samantha A. Seaward

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450 lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450 lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Hawaii Cancer Care Inc - Waterfront Plaza

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-524-6115 i.webster@hawaiicancercare.com

Principal Investigator:

Valerie Ferguson

Straub Clinic and Hospital

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-522-4333

Principal Investigator:

Valerie Ferguson

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Valerie Ferguson

Tripler Army Medical Center

Recruiting

Honolulu, Hawaii, United States, 96859

Contacts

Site Public Contact

808-433-6336

Principal Investigator:

Jeffrey L. Berenberg

Hawaii Cancer Care - Westridge

Recruiting

‘Aiea, Hawaii, United States, 96701

Contacts

Site Public Contact

808-539-2273 info@hawaiicancercare.com

Principal Investigator:

Valerie Ferguson

Pali Momi Medical Center

Recruiting

‘Aiea, Hawaii, United States, 96701

Contacts

Site Public Contact

808-486-6000

Principal Investigator:

Valerie Ferguson

OSF Saint Anthony's Health Center

Recruiting

Alton, Illinois, United States, 62002

Contacts

Site Public Contact

618-463-5623

Principal Investigator:

Jay W. Carlson

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Rice Memorial Hospital

Recruiting

Willmar, Minnesota, United States, 56201

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Site Public Contact

952-993-1517 mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Site Public Contact

573-302-2768 clinicaltrials@lakeregional.com

Principal Investigator:

Jay W. Carlson

Noyes Memorial Hospital/Myers Cancer Center

Recruiting

Dansville, New York, United States, 14437

Contacts

Site Public Contact

WCICTOresearch@urmc.rochester.edu

Principal Investigator:

Karen M. Mustian

Northwell Health/Center for Advanced Medicine

Recruiting

Lake Success, New York, United States, 11042

Contacts

Site Public Contact

516-734-8896

Principal Investigator:

Regina A. Jacob

Highland Hospital

Recruiting

Rochester, New York, United States, 14620

Contacts

Site Public Contact

585-341-8113

Principal Investigator:

Karen M. Mustian

Pluta Cancer Center

Recruiting

Rochester, New York, United States, 14623

Contacts

Site Public Contact

888-823-5923 ctsucontact@westat.com

Principal Investigator:

Karen M. Mustian

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Karen M. Mustian

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Site Public Contact

WCICTOresearch@urmc.rochester.edu

Principal Investigator:

Karen M. Mustian

Novant Health Breast Surgery - Greensboro

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Site Public Contact

336-718-8335 pjordan@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Cancer Institute - Kernersville

Recruiting

Kernersville, North Carolina, United States, 27284

Contacts

Site Public Contact

336-718-8335 asmarrs@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Cancer Institute - Mount Airy

Recruiting

Mount Airy, North Carolina, United States, 27030

Contacts

Site Public Contact

336-718-8335 asmarrs@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Cancer Institute - Statesville

Recruiting

Stateville, North Carolina, United States, 28625

Contacts

Site Public Contact

336-718-8335 pjordan@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Cancer Institute - Thomasville

Recruiting

Thomasville, North Carolina, United States, 27360

Contacts

Site Public Contact

336-718-8335 pjordan@novanthealth.org

Principal Investigator:

Judith O. Hopkins

Novant Health Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Site Public Contact

336-718-8335 pjordan@novanthealth.org

Principal Investigator:

Judith O. Hopkins

South Central Medical and Resource Center

Recruiting

Lindsay, Oklahoma, United States, 73052

Contacts

Site Public Contact

405-756-1414

Principal Investigator:

Zsolt Nagykaldi

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251 HemonCCTrials@geisinger.edu

Principal Investigator:

Nadia N. Ramdin

Geisinger Cancer Center Dickson City

Recruiting

Dickson City, Pennsylvania, United States, 18519

Contacts

Site Public Contact

877-204-6081 hemoncctrials@geisinger.edu

Principal Investigator:

Nadia N. Ramdin

Community Medical Center

Recruiting

Scranton, Pennsylvania, United States, 18510

Contacts

Site Public Contact

570-703-4768 HemonCCTrials@geisinger.edu

Principal Investigator:

Nadia N. Ramdin

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251 HemonCCTrials@geisinger.edu

Principal Investigator:

Nadia N. Ramdin

Chesapeake Regional Medical Center

Recruiting

Chesapeake, Virginia, United States, 23320

Contacts

Site Public Contact

CancerCare@ChesapeakeRegional.com

Principal Investigator:

Antonio J. Ruiz

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Site Public Contact

920-364-3604 ResearchDept@thedacare.org

Principal Investigator:

Daisy Boehm

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Site Public Contact

920-433-8889 WI_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Site Public Contact

920-433-8889 wi_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581 oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581 oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

More Information

Sponsor

University of Rochester

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-01-13.