Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
With
PRIMARY OBJECTIVE: I. To determine whether an automated, personalized physical activity (PA) intervention using wearable technology increases the proportion of patients with ovarian or endometrial cancer who achieve at least 150 minutes of moderate to vigorous physical activity (MVPA) per week by the end of the first 3 months, compared to standard recommendations. SECONDARY OBJECTIVES: I. To assess whether the physical activity (PA) intervention leads to sustained increases in physical activity levels among patients with ovarian or endometrial cancer by measuring the proportion of participants who maintain at least 150 minutes of moderate to vigorous physical activity (MVPA) per week on average during the last three months of the intervention period (months 4 to 6). II. To evaluate changes in average weekly active minutes from baseline to 3 months and 6 months between the intervention and control groups. III. To evaluate the effect of the PA intervention on quality of life among ovarian and endometrial cancer patients, as measured by validated questionnaires. IV. To assess changes in physical functioning and activities of daily living between the intervention and control groups. OUTLINE: Patients are randomized to 1 of 2 groups. ARM I: (PA INTERVENTION): Patients receive personalized PA goals and positive feedback to increase participation in MVPA in 10-15 minute increments up to 150 minutes per week for 12 weeks then sustain participation for an additional 12 weeks (6 months total). Patients also receive ongoing support to maintain or further increase PA levels up to month 6. Patients wear a Fitbit Sense 2 and CGM device continuously throughout the 6 month intervention. Additionally, patients undergo blood sample collection throughout the study. ARM II (STANDARD PA): Patients receive general PA counseling recommending 150 minutes of activity per week consistent with standard of care at time of enrollment. Patients also wear a Fitbit and continuous glucose monitor (CGM) device for 6 months. Additionally, patients undergo blood sample collection throughout the study. After completion of study intervention, patients are followed up every 3 months for up to 24 months after enrollment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
