Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovary Cancer
- Sponsor
- Northwestern University
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Change in Physical Activity
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Gynecologic cancers include ovarian, uterine and cervical cancers and represent 102,000 cases of cancer in the United States every year; 60% occur in women greater than age 60. Older patients with gynecologic cancers have higher rates of advanced stage at presentation, more aggressive histology and more commonly require adjuvant treatment with systemic therapies such as chemotherapy, immunotherapy or targeted therapies. This chemotherapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life, and ultimately, less systemic therapy completion and inferior cancer survival. Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty. In fact, physical activity, and the multi-system health benefits that result, is the most recommended frailty intervention. Physical activity interventions in cancer survivors reduce sedentary time, decrease functional decline, and lower mortality. Studies specific to patients on active cancer treatment are less common, however, several randomized trials have found less decline in cardiorespiratory fitness, less chemotherapy toxicity, and fewer chemotherapy dose reductions. Although older adults with gynecologic cancer have a high likelihood of benefit from physical activity, challenges exist in accessing current interventions. Traditional in-person strenuous physical activity interventions with static goals may not be appropriate for older women undergoing chemotherapy, where symptom burden is high and varied, and healthcare visits frequent. Remotely delivered mobile health (mHealth) technology-based physical activity interventions increase physical activity in diverse populations including those with metastatic cancer. Four evidence-based strategies to increase physical activity have demonstrated efficacy in cancer patients and older adults, including, 1) symptom burden tailored goal setting 2) exercise partners 3) oncology provider engagement and 4) coaching. This study will determine which components of a physical activity intervention (Fit4Treatment) meaningfully contribute to improving physical activity (steps) among older women with gynecologic cancer receiving systemic treatment such as chemotherapy.
Investigators
Emma Barber
Assistant Professor
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •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
- •Fluent in English
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Physical Activity
Time Frame: 24 weeks
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.
Secondary Outcomes
- Adverse Events(3 years)
- Survival Outcomes(3 years)
- Change in Pain Interference(24 weeks)
- Change in Anxiety(24 weeks)
- Change in Functional Performance(24 weeks)
- Change in Frailty(24 weeks)
- Change in Fatigue(24 weeks)
- Change in Physical Function(24 weeks)
- Change in Sleep Disturbance(24 weeks)
- Change in Global Quality of Life(24 weeks)
- Treatment Complications(3 years)
- Treatment Outcomes(3 years)
- Healthcare Utilization(3 years)