Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
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
Interventions
Best Practice
Comprehensive Geriatric Assessment
Educational Intervention
Exercise Intervention
Questionnaire Administration
Tailored Intervention
Conditions
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