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

NCT06855706 | Recruiting

• 3 other identifiers: I 4260824NCI-2025-00835P50CA159981
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Stage IV Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; 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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving ≥ 150 minutes of moderate to vigorous physical activity (MVPA) per week

  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.

  At 3 months (weeks 11 and 12)

Secondary Outcomes (7)

• Proportion of participants maintaining ≥150 minutes of MVPA per week on average

  During months 4-6 (weeks 13-24) of the intervention period

• Mean change in average weekly active minutes

  From baseline to 3 and 6 months

• Changes in quality of life (QOL) scores -Ovarian Cancer Module

  From baseline to 3 and 6 months

• Changes in Quality of life

  From baseline to 3 and 6 months

• Change in Quality of Life Score- Endometrial

  From baseline to 3 and 6 months

Study Arms (2)

Arm I (Personalized Physical Activity intervention)

EXPERIMENTAL

Patients receive personalized PA goals and positive feedback to increase participation in MVPA in 10-15 minute increments up to 150 minutes per week for 12 weeks then sustain participation for an additional 12 weeks (6 months total). Patients also receive ongoing support to maintain or further increase PA levels up to month 6. Patients wear a Fitbit Sense 2 and CGM device continuously throughout the 6 month intervention. Additionally, patients undergo blood sample collection throughout the study.

Behavioral: Behavioral Intervention; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Supportive Care

Arm II (Standard PA)

ACTIVE COMPARATOR

Patients receive general PA counseling recommending 150 minutes of activity per week consistent with standard of care at time of enrollment. Patients also wear a Fitbit Sense 2 and CGM device for 6 months. Additionally, patients undergo blood sample collection throughout the study.

Other: Best Practice; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Receive personalized PA goals and positive feedback

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm I (Personalized Physical Activity intervention)

Best Practice OTHER

Receive general PA counseling

Also known as: standard of care, standard therapy

Arm II (Standard PA)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (Personalized Physical Activity intervention); Arm II (Standard PA)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (Personalized Physical Activity intervention); Arm II (Standard PA)

Exercise Intervention OTHER

Participate in MVPA

Arm I (Personalized Physical Activity intervention)

Medical Device Usage and Evaluation OTHER

Wear a Fitbit Sense 2 and CGM device

Arm I (Personalized Physical Activity intervention); Arm II (Standard PA)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Personalized Physical Activity intervention); Arm II (Standard PA)

Supportive Care OTHER

Receive ongoing support

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm I (Personalized Physical Activity intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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)

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:
• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Behavior Therapy; Practice Guidelines as Topic; Standard of Care; Specimen Handling; Palliative Care

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emese Zsiros

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 4, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

US (1)