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

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.

Conditions

• Endometrial Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Stage II Fallopian Tube Cancer AJCC v8
• Stage II Ovarian Cancer AJCC v8
• Stage II Primary Peritoneal Cancer AJCC v8
• Stage III Fallopian Tube Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Primary Peritoneal Cancer AJCC v8
• Stage IV Fallopian Tube Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Primary Peritoneal Cancer AJCC v8

Interventions

BEHAVIORAL

Behavioral Intervention

Receive personalized PA goals and positive feedback

OTHER

Best Practice

Receive general PA counseling

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Exercise Intervention

Participate in MVPA

OTHER

Medical Device Usage and Evaluation

Wear a Fitbit Sense 2 and CGM device

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Supportive Care

Receive ongoing support

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Emese Zsiros · Roswell Park Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-04

Primary Completion

2027-04-30

Completion

2028-04-30

Countries

• United States

Study Locations