Life on the Go 3 Study Using Wearable Devices to Personalize Physical Activity and Improve Immune Function and Outcomes in Patients with Stage II-IV Ovarian, Primary Peritoneal, Fallopian Tube, or Newly Diagnosed Endometrial Cancer

What this Trial Is About

Researchers are evaluating an automated, personalized physical activity intervention supported by wearable technology in patients with stage II-IV ovarian, primary peritoneal, fallopian tube, or newly diagnosed endometrial cancer. The study aims to see if this intervention can increase physical activity levels, improve quality of life, and positively affect immune function compared to standard care. It also explores how physical activity impacts the gut microbiome and immune system in these patients. Participants are randomly assigned to one of two groups. The first group receives personalized physical activity goals with positive feedback to gradually increase moderate to vigorous activity up to 150 minutes per week over 12 weeks, then sustain or increase activity for another 12 weeks, totaling 6 months. They wear a Fitbit Sense 2 and a continuous glucose monitor CGM throughout. The second group receives general physical activity counseling recommending 150 minutes per week, along with the same device usage and monitoring. Both groups undergo blood sample collection during the study period. Participants are monitored for 6 months during the intervention, wearing devices daily and participating in questionnaires, blood, and stool sample collections. After finishing the intervention, they are followed every 3 months for up to 24 months. The study measures include the proportion of participants achieving at least 150 minutes of moderate to vigorous activity weekly, changes in physical activity levels, quality of life, physical function, and daily living activities. Safety and other health measures are also assessed throughout the study.

An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study