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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
668
Receive usual follow-up survivorship care
Complete geriatric assessment
Participate in survivorship health education sessions
Participate in SHE-EXCAP program
Ancillary studies
Participate in GEM consultation
Lewis and Faye Manderson Cancer Center
Tuscaloosa, Alabama, United States
RECRUITINGKaiser Permanente-Fremont
Fremont, California, United States
RECRUITINGKaiser Permanente-San Francisco
San Francisco, California, United States
RECRUITINGHelen F Graham Cancer Center
Newark, Delaware, United States
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).
Time frame: Up to 6 months
Patient-reported cognitive function
Will be assessed by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) Function in older cancer survivors. The FACT-Cog is a 37-item questionnaire, each with a 5-point Likert scale response. The FACT-Cog provides an overall score and subdomain scores (perceived cognitive impairment \[PCI\], perceived abilities, comments from others, and impact on quality of life). The secondary aim will be the PCI score at 6 months.
Time frame: Up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
RECRUITINGHawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
RECRUITINGStraub Clinic and Hospital
Honolulu, Hawaii, United States
RECRUITINGKapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
RECRUITINGTripler Army Medical Center
Honolulu, Hawaii, United States
RECRUITINGHawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
RECRUITING...and 35 more locations