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NCT05006482PHASE3RecruitingAccepts Healthy Volunteers

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

University of Rochester

Start Date

3/21/2023

Completion Date

9/17/2027

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.

Detailed Description

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

Age Range: 18 years to No maximum

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

Interventions

OTHER

Best Practice

OTHER

Comprehensive Geriatric Assessment

OTHER

Educational Intervention

OTHER

Exercise Intervention

OTHER

Questionnaire Administration

PROCEDURE

Tailored Intervention

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Conditions

LymphomaMalignant Solid Neoplasm

Locations

Lewis and Faye Manderson Cancer Center

Tuscaloosa, Alabama 35401

United States

Kaiser Permanente-Fremont

Fremont, California 94538

United States

Kaiser Permanente-San Francisco

San Francisco, California 94115

United States

Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware 19713

United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii 96813

United States

Straub Clinic and Hospital

Honolulu, Hawaii 96813

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii 96826

United States

Tripler Army Medical Center

Honolulu, Hawaii 96859

United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii 96701

United States

Pali Momi Medical Center

‘Aiea, Hawaii 96701

United States

OSF Saint Anthony's Health Center

Alton, Illinois 62002

United States

Fairview Southdale Hospital

Edina, Minnesota 55435

United States

Hennepin County Medical Center

Minneapolis, Minnesota 55415

United States

Monticello Cancer Center

Monticello, Minnesota 55362

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota 55416

United States

Regions Hospital

Saint Paul, Minnesota 55101

United States

Lakeview Hospital

Stillwater, Minnesota 55082

United States

Rice Memorial Hospital

Willmar, Minnesota 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota 55125

United States

Lake Regional Hospital

Osage Beach, Missouri 65065

United States

Noyes Memorial Hospital/Myers Cancer Center

Dansville, New York 14437

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York 11042

United States

Highland Hospital

Rochester, New York 14620

United States

Pluta Cancer Center

Rochester, New York 14623

United States

University of Rochester

Rochester, New York 14642

United States

Wilmot Cancer Institute at Webster

Webster, New York 14580

United States

Novant Health Breast Surgery - Greensboro

Greensboro, North Carolina 27403

United States

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina 27284

United States

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina 27030

United States

Novant Health Cancer Institute - Statesville

Stateville, North Carolina 28625

United States

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina 27360

United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

South Central Medical and Resource Center

Lindsay, Oklahoma 73052

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Geisinger Cancer Center Dickson City

Dickson City, Pennsylvania 18519

United States

Community Medical Center

Scranton, Pennsylvania 18510

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Chesapeake Regional Medical Center

Chesapeake, Virginia 23320

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin 54911

United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin 54701

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin 54303

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin 54482

United States

Marshfield Medical Center - Weston

Weston, Wisconsin 54476

United States