Recruiting

Fit4Treatment

Sponsor:

Northwestern University

Code:

NCT05743517

Conditions

Ovary Cancer

Endometrial Cancer

Uterine Cancer

Cervical Cancer

Cervix Cancer

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Fit4Treatment

Study Details

Brief summary:

The primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.

Conditions

Ovary Cancer

Endometrial Cancer

Uterine Cancer

Cervical Cancer

Cervix Cancer

Study ID

NCT05743517

Start date

Sep 15, 2023

Status verified date

May, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female; > 60 years of age
  • Diagnosis of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer
  • Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)
  • Willing to try to identify an exercise partner to participate with them, if needed
  • Fluent in English

Exclusion Criteria:

  • Uncontrolled cardiovascular disease or other major contraindications to physical activity
  • Active brain metastases
  • Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention
  • Pregnant women or prisoners

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Symptom burden-tailored goal setting app

The Fit4Treatment app is designed to encourage physical activity among older women with gynecologic cancer while they are undergoing cancer therapy. The app will contain the following features 1) education about safely increasing physical activity and steps; 2) tailored patient-specific push notifications to encourage physical activity 3) syncing of Fitbit steps and transmission of these data to study staff in real time; 4) daily, weekly and monthly step progress; and 5) goal setting that incorporates prior physical activity, patient desires, and daily symptom burden. The app will prompt patients to report their symptom burden on a scale of 1-5 each morning. Based on their symptom rating and the previous days step counts (measured directly by the Fitbit) patients will be provided with three different goal choices to select. Daily activity goals increase, decrease or stay the same depending on the previous day and the patient's own goals.

experimental: Exercise Partner

Participants assigned to the exercise partner component will be encouraged to discuss their step progress with their selected partner who will in turn support the participant and encourage them to stay active.

experimental: Provider/oncologist engagement

Participants assigned to the provider/oncologist engagement component will have their physical activity data recorded by the Fitbit shared with their oncology provider through the electronic medical record (EMR). For participants randomized to this condition, clinical staff will place an order into the EMR, allowing the patient to use the patient-facing portal MyChart to link their Fitbit to the health record. Prior to regularly scheduled clinic visits, the patient's oncology team will receive a message summarizing the participant's physical activity (average daily steps) for the prior three weeks.

experimental: Coaching

Participants assigned to the coaching intervention will receive weekly coaching calls. The study team will call them at a previously specified and mutually agreed upon time once per week to review topics related to physical activity and cancer treatment. Coaching calls will have an educational component and cover topics such as reducing sedentary behavior, benefits of increased physical activity, managing cancer treatment symptoms, social support, stress management, etc. During these calls, the topics as well as strategies and recommendations will be discussed. Barriers and facilitators will be reflected on and planned for to increased self-efficacy. Participants will engage in direct problem solving with their coach. Discussing these topics will enhance outcome expectation and increase motivation.

Interventions

Fit4Treatment

This study will test the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity. The intervention will be delivered over 12 weeks with a 12 week follow up period.

Primary outcome measure

  • Change in Physical Activity [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Emma Barber, MD

More Information

Sponsor

Northwestern University

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • behavioral intervention
  • physical activity
  • cancer outcomes
  • chemotherapy
  • systemic therapy
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-29.