Actively Recruiting
Life on the Go 3: A Randomized Trial of Automated Personalized Physical Activity Using Wearable Devices to Improve Immune Function and Outcomes in Ovarian and Endometrial Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-01-06
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Clinical suspicion or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer, or biopsy-proven pre-operative endometrial cancer with planned treatment
- Willing to wear an activity tracking device for at least 70% of waking hours (11 hours/day) during the 6-month study
- Under the care of Roswell Park Comprehensive Cancer Center during the study period
- Willing to participate in questionnaires and blood and stool collection during the study
- Able to provide informed consent and understand the investigational nature of the study
- Have a smartphone with daily internet access compatible with the study devices
You will not qualify if you...
- Unstable serious psychiatric illness including schizophrenia, bipolar disorder, severe major depression, severe personality disorders, recent suicide attempt or psychiatric hospitalization within the past 12 months
- Life expectancy less than 12 months
- History of invasive malignancies within the last 2 years except non-melanoma skin cancer or in situ cervical cancer
- Resting heart rate over 120 bpm after 10 minutes seated rest on two measurements
- High blood pressure (systolic >180 mmHg or diastolic >100 mmHg) after 10 minutes seated rest on two measurements
- Unstable angina or heart attack within the past 3 months
- Pregnant or nursing
- Cognitive impairment or language barriers preventing consent or compliance
- Lack of access to necessary technology
- Conditions posing risk during increased physical activity or interfering with compliance
- Declining to provide valid contact information or consent to receive study messages
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive personalized or standard physical activity counseling and wear wearable devices continuously while engaging in moderate to vigorous physical activity to improve immune function and clinical outcomes over a 6-month period.
Continuous device use and ongoing physical activity with periodic blood sample collections
Duration - Up to 24 months
Participants are followed up every 3 months for up to 24 months after the intervention to monitor long-term outcomes.
Visits every 3 months
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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