The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.
Female; > 60 years of age
Diagnosis of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer
Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)
Willing to try to identify an exercise partner to participate with them, if needed
Uncontrolled cardiovascular disease or other major contraindications to physical activity
Active brain metastases
Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention
Pregnant women or prisoners
Factorial
Fit4Treatment
BehavioralThis study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.
Change in Physical Activity
The primary outcome of average steps per day over a 7 day period will be measured with Actigraph. Patients will wear an accelerometer for 7 days prior to study intervention, 7 days at the conclusion of the 12-week Fit4Treatment intervention, and 7 days at the conclusion of the 12 week follow up period.
Change in Functional Performance
Patients will complete the short performance physical battery (SPPB). This is a well validated physical performance measure specifically in an older patient population and consists of balance testing, a 4-meter walk test and timed standing from a chair.
Change in Frailty
Frailty will be assessed using the Fried's phenotype method.
Change in Anxiety
Patient Reported Outcomes Measurement Information System (PROMIS) for anxiety will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 7a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.
Change in Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) for fatigue will be measured at baseline, after the 12-week intervention, and after 24 weeks using Patient Reported Outcomes Measurement Information System Item Bank v1.0 - Fatigue - Short Form 7a, using a scale of 1-5, where 1 is the best outcome. PROMIS measures are validated, reliable measures of health states that can be completed with minimal patient burden and have been used in myriad studies of both older adults and cancer patients.
Click on the lead sponsor to view all of their trials.
