This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06855706.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Active
Contact: Emese Zsiros
Phone: 716-845-8337
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 (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.
ARM II (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 and CGM device continuously throughout the 6 month intervention. 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.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorEmese Zsiros
