Life on the Go 3: A Randomized Controlled Trial of Automated, Personalized Physical Activity Intervention Using Wearable Devices to Improve Immune Function and Clinical Outcomes in Ovarian and Endometrial Cancer Patients
Summary
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.
Detailed description
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.
Arms & interventions
- BehavioralBehavioral Intervention
Receive personalized PA goals and positive feedback
- OtherBest Practice
Receive general PA counseling
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherExercise Intervention
Participate in MVPA
- OtherMedical Device Usage and Evaluation
Wear a Fitbit Sense 2 and CGM device
- OtherQuestionnaire Administration
Ancillary studies
- OtherSupportive Care
Receive ongoing support
Outcome measures
Primary
Proportion of participants achieving ≥ 150 minutes of moderate to vigorous physical activity (MVPA) per week
Will be defined based on Fitbit's activity intensity levels (e.g., minutes spent in moderate and vigorous zones). Fisher's exact test will be used to compare proportions between groups. Will use logistic regression for adjustments for baseline physical activity levels if necessary. A two-sided alpha = 0.05 will be used for statistical significance.
Time frame: At 3 months (weeks 11 and 12)
Secondary
Proportion of participants maintaining ≥150 minutes of MVPA per week on average
Time frame: During months 4-6 (weeks 13-24) of the intervention period
Mean change in average weekly active minutes
Time frame: From baseline to 3 and 6 months
Changes in quality of life (QOL) scores -Ovarian Cancer Module
Time frame: From baseline to 3 and 6 months
Changes in Quality of life
Time frame: From baseline to 3 and 6 months
Change in Quality of Life Score- Endometrial
Time frame: From baseline to 3 and 6 months
Functional Status
Time frame: From baseline to 3 and 6 months
Functional Status - Katz Index of Activities Daily Living
Time frame: From baseline to 3 and 6 months
Eligibility criteria
Study locations (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263