RecruitingNot ApplicableNCT06855706

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

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


Sponsor

Roswell Park Cancer Institute

Enrollment

120 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a personalized activity coaching program using a wearable fitness tracker can help women with ovarian, fallopian tube, peritoneal, or endometrial cancer stay more active, support their immune system, and improve their health outcomes during treatment. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with stage II–IV ovarian, primary peritoneal, or fallopian tube cancer (or recurrent disease), OR newly diagnosed endometrial cancer requiring surgery or other treatment - You are willing to wear a fitness tracker for at least 11 hours per day throughout the 6-month study - You have a smartphone compatible with the study apps - You are receiving care at Roswell Park Comprehensive Cancer Center **You may NOT be eligible if:** - You have a serious unstabilized psychiatric illness (e.g., schizophrenia, severe depression, recent suicide attempt) - Your life expectancy is less than 12 months - You have had another invasive cancer in the past 2 years (except skin cancer or in situ cervical cancer) - Your resting heart rate or blood pressure is dangerously high - You had a heart attack or unstable chest pain in the past 3 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06855706


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