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
Roswell Park Cancer Institute
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.
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 participa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years old on day of signing informed consent * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Participant must satisfy one of the following conditions: * Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest poin…
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
Location
- Roswell Park Cancer InstituteBuffalo, New York