Home Based Exercise Program for Elderly Cancer Patients
- Conditions
- Cancer Related Fatigue
- Interventions
- Behavioral: Home Based Exercise
- Registration Number
- NCT01990066
- Lead Sponsor
- Duke University
- Brief Summary
Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient
Problem:
Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?
Support:
Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).
The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.
Methods:
This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.
Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.
The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).
Conclusion:
PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 8
- Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy
- Age greater than or equal to 65yrs
- ECOG (Eastern Cooperative Oncology Group) performance status less than 3
- No current physical therapy intervention
- English speaking
- Non-gynecologic malignancy
- Recurrent cancer
- Receiving radiation alone
- Gait or balance disturbance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Home Based Exercise Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.
- Primary Outcome Measures
Name Time Method Reduction in Cancer Related Fatigue (CRF) Baseline, +/- 7days of 4th chemo cycle (mid point), +/- 7 days of 3 weeks after 6th cycle (end point) CRF will be evaluated using the FACIT-F tool.
- Secondary Outcome Measures
Name Time Method Reduction in Physical Functional Decline Baseline and +/- 7days of 3 weeks post 6th cycle (end point) Physical function will be evaluated using the Berg Balance Test and 6 Min Walk Test
Quality of Life Improvement (QOL) Baseline, +/- 7days of cycle 4 of treatment (mid point), +/- 7 days of 3rd week after cycle 6 (end point) QOL will be evaluated using the NHANES and FACIT-F tools.
Trial Locations
- Locations (1)
Duke Raleigh Cancer Center
🇺🇸Raleigh, North Carolina, United States