Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by Roswell Park Cancer Institute · Updated on 2026-01-06

120

Participants Needed

1

Research Sites

151 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

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older on the day of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer and may be awaiting staging surgery or biopsy followed by chemotherapy
  • Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any recurrence point
  • Have pre-operative biopsy-proven endometrial cancer planned for surgical or medical management
  • Willing to wear the activity tracking device for at least 70% of waking hours (11 hours/day) during the 6-month study
  • Under care of Roswell Park Comprehensive Cancer Center for treatment, surgery, surveillance, or consultation
  • Willing to participate in questionnaires, blood and stool collection for research
  • Understand the investigational nature and sign informed consent
  • Have a compatible smartphone with daily internet access
Not Eligible

You will not qualify if you...

  • Serious unstable psychiatric illness including schizophrenia, bipolar disorder, severe depression, severe personality disorders, recent suicide attempt or psychiatric hospitalization within 12 months
  • Life expectancy less than 12 months as judged by investigator
  • History of other invasive cancers within last 2 years except non-melanoma skin cancer or in situ cervical cancer
  • Resting heart rate over 120 beats per minute after 10 minutes seated rest on two measurements
  • Blood pressure over 180/100 mmHg after 10 minutes seated rest on two measurements
  • Unstable angina or myocardial infarction within past 3 months
  • Pregnant or nursing
  • Unable or unwilling to follow protocol requirements including cognitive impairment, language barriers without translation, lack of compatible technology, or other factors affecting adherence
  • Any condition deemed unsuitable by investigator including severe pulmonary disease, uncontrolled metabolic disorders, or other significant medical risks
  • Do not provide a valid cell phone number or do not consent to receive SMS messages for study monitoring

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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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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