Cervical Cancer Clinical Trial
Official title:
Patient-Tailored Physical Activity Intervention Among Older Women With Gynecologic Cancers Undergoing Chemotherapy (Fit4Treatment)
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.
Status | Recruiting |
Enrollment | 192 |
Est. completion date | August 1, 2029 |
Est. primary completion date | August 1, 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks | |
Secondary | Change in Frailty | Frailty will be assessed using the Fried's phenotype method. | 24 weeks | |
Secondary | 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. |
24 weeks | |
Secondary | 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. |
24 weeks | |
Secondary | Change in Physical Function | Patient Reported Outcomes Measurement Information System (PROMIS) for physical function 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 - Physical Function - Short Form 10a, 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. |
24 weeks | |
Secondary | Change in Pain Interference | Patient Reported Outcomes Measurement Information System (PROMIS) for pain 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 - Pain Interference - Short Form 6a, 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. |
24 weeks | |
Secondary | Change in Sleep Disturbance | Patient Reported Outcomes Measurement Information System (PROMIS) for sleep disturbance 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 - Sleep Disturbance - Short Form 6a, using a scale of 1-5, where 1 or 5 is the best outcome, depending on the question.
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. |
24 weeks | |
Secondary | Change in Global Quality of Life | Quality of Life will be measured at baseline, after the 12-week intervention, and after 24 weeks using the Global Quality of Life (QOL) scale of 1-5, where 5 is the best outcome. | 24 weeks | |
Secondary | Treatment Outcomes | Medical record review will be performed to examine treatment(s) administered and treatment delays. | 3 years | |
Secondary | Treatment Complications | Medical record review will be performed to monitor complications of systemic treatment. | 3 years | |
Secondary | Healthcare Utilization | Medical record review will be performed to monitor for hospitalizations, emergency room visits, and unscheduled clinic visits. | 3 years | |
Secondary | Survival Outcomes | Medical records will be reviewed for three years to monitor for cancer recurrence. | 3 years | |
Secondary | Adverse Events | The number of adverse events will be recorded and graded according to Common Terminology Criteria for Adverse Events, v5.0. | 3 years |
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