Physical Activity Intervention for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEmese Zsiros

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with stage II-IV ovarian, primary peritoneal, fallopian tube cancer or newly diagnosed endometrial cancer. Participants should be interested in a physical activity program using wearable technology compared to standard care.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study

I am 18 years old or older.

+6 more

Exclusion Criteria

Serious psychiatric illness that is not currently stabilized

Life expectancy of less than 12 months

Resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements

+5 more

Participant Groups

The study tests an automated personalized physical activity intervention against standard care. It uses wearables to encourage exercise and assesses its impact on quality of life, physical function, the gut microbiome, and immune function in certain cancer patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (personalized physical activity intervention)Experimental Treatment7 Interventions

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.

Group II: Arm I (standard PA)Active Control5 Interventions

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 CGM device for 6 months. Additionally, patients undergo blood sample collection throughout the study.