Life on the Go 3 Study: Physical Activity for Ovarian and Endometrial Cancers
This study is looking at whether a personalized physical activity program, using wearable technology, can improve immune function and health for people with certain types of ovarian, primary peritoneal, fallopian tube, or newly diagnosed endometrial cancer. You would either receive personalized physical activity goals and positive feedback, or general physical activity advice. Researchers want to see if the personalized program helps more people reach at least 150 minutes of moderate to vigorous physical activity (MVPA) each week within three months, compared to standard recommendations. They will also look at your quality of life and physical abilities. The study aims to enroll 120 participants.
- Study design
- This is an interventional study where participants are randomly assigned to one of two groups. It aims to enroll 120 participants.
- What's involved
- You would undergo blood sample collection and participate in moderate to vigorous physical activity. The primary goal is measured at 3 months (weeks 11 and 12), with secondary goals measured up to 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study evaluates sustained increases in physical activity levels and other outcomes up to 6 months after the intervention begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06855706
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
Recruiting
NAAges 18+InterventionalSupportive careRoswell Park Cancer InstituteInvestigator-initiated
~120 participants
Updated 2026-01-06 on ClinicalTrials.gov
What's tested:Behavioral InterventionBest PracticeBiospecimen CollectionElectronic Health Record ReviewExercise InterventionMedical Device Usage and Evaluation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving ≥ 150 minutes of moderate to vigorous physical activity (MVPA) per week
Measured over At 3 months (weeks 11 and 12)
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Emese Zsiros · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery
Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management
willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours/day) throughout the 6-month study period
under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following:
Receiving cancer treatment at Roswell Park Comprehensive Cancer Center
Undergoing surgery at Roswell Park Comprehensive Cancer Center
Participating in surveillance visits at Roswell Park Comprehensive Cancer Center
Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers
willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes
Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications)
NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function
Exclusion
serious psychiatric illness that is not currently stabilized, including but not limited to:
Schizophrenia or other psychotic disorders
Bipolar disorder
Sever major depressive disorder
Severe personality disorders diagnosed by a qualified mental health professional
Recent suicide attempt or psychiatric hospitalization within the previous 12 months
Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools
history of other invasive malignancies within the last two years, except for:
Non-melanoma skin cancer
In situ cervical cancer
resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements
systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements
Unstable angina or myocardial infarction within the past 3 months.
Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention
Myocardial Infarction: Heart attack diagnosed by a medical professional
Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures.
unwilling or unable to follow the protocol requirements, including but not limited to:
Cognitive impairment that affects the ability to provide informed consent or comply with study procedures
Language barriers without access to adequate translation services
Lack of access to necessary technology (e.g., smartphones compatible with study devices)
Other factors that would prevent adherence to study protocols
Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to:
Severe pulmonary disease
Uncontrolled metabolic disorders
Other significant medical conditions that pose a risk during increased physical activity
Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.
What this trial measures
- Proportion of participants achieving ≥ 150 minutes of moderate to vigorous physical activity (MVPA) per weekAt 3 months (weeks 11 and 12)
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.