Patient-Tailored Physical Activity to Improve Health and Survival in Older Women with Gynecologic Cancers Undergoing Chemotherapy, Fit4Treatment Trial
This trial tests how well patient tailored physical activity interventions work to improve health and survival among older women with gynecologic cancers undergoing chemotherapy. 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. Engaging in patient tailored physical activity may safely and gradually increase physical activity in gynecologic cancer patients and lead to improved health and survival among older women with gynecologic cancers who are undergoing chemotherapy.
Inclusion Criteria
- PATIENTS: Female; >= 60 years of age
- PATIENTS: Diagnosis or suspicion of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer
- PATIENTS: Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)
- PATIENTS: Willing to try to identify an exercise partner to participate with them, if needed
- PATIENTS: Fluent in English
- EXERCISE PARTNERS: 18 years old or older
- EXERCISE PARTNERS: Willing to use a Fitbit and share Fitbit data with the study team
- EXERCISE PARTNERS: Fluent in English
Exclusion Criteria
- PATIENTS: Uncontrolled cardiovascular disease or other major contraindications to physical activity
- PATIENTS: Active brain metastases
- PATIENTS: Cognitive or functional limitations that preclude a patient’s ability to participate in the physical activity intervention
- PATIENTS: Pregnant women or prisoners
- EXERCISE PARTNERS: Under 18 years of age
- EXERCISE PARTNERS: Uncontrolled cardiovascular disease or other major contraindications to physical activity
Additional locations may be listed on ClinicalTrials.gov for NCT05743517.
Locations matching your search criteria
United States
Illinois
Chicago
PRIMARY OBJECTIVES:
I. To identify which of the four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) of the Fit4Treatment intervention meaningfully contribute to improvements in average daily steps using a multi-phase optimization strategy (MOST) full factorial clinical trial.
II. To test how changes in physical activity, as measured by steps, improve patient reported outcomes (physical function, fatigue), aging outcomes (frailty, functional performance) and cancer outcomes (treatment delays, progression free survival).
III. To examine potential mediators (adherence, self-efficacy) and moderators (age, treatment dose, cancer type) of the four components of the Fit4Treatment intervention on steps.
OUTLINE: Patients are randomized to 1 of 16 groups.
GROUP I: Patients receive access to the Fit4Treatment application (app) and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3,10-15 minute educational phone calls while on study. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Patients receive access to Northwestern Medicine (NM) MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP II: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP III: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP IV: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP V: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP VI: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP VII: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP VIII: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients track their symptoms daily, choose tailored activity goals in the Fit4Treatment app based on their symptoms and receive education and reminders about physical activity. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP IX: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP X: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XI: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XII: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XIII: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XIV: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients receive weekly, 5-15 minute coaching calls where they receive education and support. Patients receive access to NM MyChart app where activity data will be available for the provider to view and discuss with the patient. Patients and their provider receive messages with physical activity data to prompt discussion. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XV: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Patients choose an exercise partner who also receives access to the Fit4Treatment app and encourages the patient to stay active. Exercise partners complete 3, 10-15 minute educational phone calls while on study. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
GROUP XVI: Patients receive access to the Fit4Treatment app and are provided education on how to increase physical activity in a gradual and safe manner. Interventions take place for 12 weeks. Patients also undergo physical activity tracking via a wearable FitBit and may undergo blood sample collection on study.
After completion of the study intervention, patients are followed up at week 24 and then periodically for up to 3 years.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorEmma Barber
- Primary IDNU 23G02
- Secondary IDsNCI-2023-07375, STU00218257
- ClinicalTrials.gov IDNCT05743517