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NCT05006482 | RECRUITING | Malignant Solid Neoplasm

Geriatric Evaluation and Management with Survivorship Health Education (GEMS) for Older Survivors of Cancer
Sponsor:

University of Rochester NCORP Research Base

Information provided by (Responsible Party):

Supriya Mohile

Brief Summary:

This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) 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. GEMS 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 GEMS 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.

Condition or disease

Malignant Solid Neoplasm

Intervention/treatment

Best Practice

Comprehensive Geriatric Assessment

Educational Intervention

Exercise Intervention

Questionnaire Administration

Tailored Intervention

Phase

NA

Detailed Description:

PRIMARY OBJECTIVE: I. To compare the efficacy of GEMS to usual care for improving patient-reported physical function (Functional Assessment of Cancer Therapy-Fatigue Physical Well-Being Subscale \[FACIT-PWB\]) in older cancer survivors at 6 months. SECONDARY OBJECTIVE: I. To compare the efficacy of GEMS to usual care for improving patient-reported cognitive function (FACT-cognitive function \[Cog\]) in older cancer survivors at 6 months. OUTLINE: Practice sites are randomized to 1 of 2 arms. Participants are assigned to arms based on practice cluster. ARM I: Patients receive routine survivorship follow-up care at their doctor's office for 5 visits over 12 months. Caregivers will be followed for 3 visits over 6 months. ARM II: Patients and caregivers participate in GEMS consultation over 1 hour that includes discussion of results and recommendations from geriatric assessment. Patients also participate in survivorship health education sessions over 75 minutes twice weekly for 4 weeks. Patients also participate in Exercise for Cancer Patients (EXCAP) program, which includes daily walking and resistance exercises.

Study Type : INTERVENTIONAL
Estimated Enrollment : 960 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Optimizing Functional Outcomes of Older Cancer Survivors After Chemotherapy
Actual Study Start Date : 2023-07-18
Estimated Primary Completion Date : 2028-06-01
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * CANCER SURVIVORS: 65 years of age or older
  • * CANCER SURVIVORS: Have completed or will have completed curative-intent adjuvant chemotherapy for any solid tumor malignancy in last 6 months. Run-in study procedures can occur during the last 4 weeks of adjuvant chemotherapy but must be completed no later than 6 months after the completion of adjuvant chemotherapy. Cancer survivors who will receive other curative-intent treatments (e.g., hormonal treatment, monoclonal antibodies, radiation) other than surgery are eligible
  • * 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 when necessary
  • * 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 read 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 University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base
  • * CAREGIVERS: 18 years of age 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 read 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
Exclusion Criteria
  • * CANCER SURVIVORS: Have surgery planned within six months of informed consent. Cancer survivors who previously had surgery are eligible
  • * 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.
Geriatric Evaluation and Management with Survivorship Health Education (GEMS) for Older Survivors of Cancer

Location Details

NCT05006482

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Kaiser Permanente NCORP (KAISER)

Vallejo, California, United States, 94589

RECRUITING

United States, Delaware

Delaware/Christiana Care NCORP (CHRISTIANA)

Newark, Delaware, United States, 19718

RECRUITING

United States, Hawaii

University of Hawaii Cancer Center

Honolulu, Hawaii, United States, 96813

RECRUITING

United States, Hawaii

Hawaii Minority Underserved NCORP

Honolulu, Hawaii, United States, 96822

RECRUITING

United States, Minnesota

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, United States, 55416

RECRUITING

United States, New York

University of Rochester NCORP Research Base

Rochester, New York, United States, 14642

RECRUITING

United States, North Carolina

Novant Health Cancer Institute - Kernersville

Winston-Salem, North Carolina, United States, 27103

RECRUITING

United States, North Carolina

Southeast Clinical Oncology Research Consortium (SCOR)

Winston-Salem, North Carolina, United States, 27104

NOT YET RECRUITING

United States, Oklahola

University of Oklahoma

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Pennsylvania

Geisinger Cancer Institute NCORP (GEISINGER)

Danville, Pennsylvania, United States, 17822

RECRUITING

United States, Wisconsin

Cancer Research of Wisconsin and Northern Michigan Consortium

Green Bay, Wisconsin, United States, 54301

RECRUITING

United States, Wisconsin

Wisconsin NCORP

Marshfield, Wisconsin, United States, 54449