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
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Roswell Park Cancer Institute
You may qualify if…
- ✓ 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 recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis
- ✓ 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:
You may not qualify if…
- ✕ 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:
Where it's recruiting
Buffalo
Source: ClinicalTrials.gov · NCT06855706 · last updated 2026-01-06