Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)

NCT05743517 | Recruiting

• 1 other identifier: STU00218257
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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; Vulvar Cancer; Vaginal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity

  The primary outcome of average steps per day over a 7 day period will be measured with Actigraph. Patients will wear an accelerometer for 7 days prior to study intervention, 7 days at the conclusion of the 12-week Fit4Treatment intervention, and 7 days at the conclusion of the 12 week follow up period.

  24 weeks

Secondary Outcomes (13)

• Change in Functional Performance

  24 weeks

• Change in Frailty

  24 weeks

• Change in Anxiety

  24 weeks

• Change in Fatigue

  24 weeks

• Change in Physical Function

  24 weeks

Study Arms (4)

Symptom burden-tailored goal setting app

EXPERIMENTAL

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.

Behavioral: Fit4Treatment

Exercise Partner

EXPERIMENTAL

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.

Behavioral: Fit4Treatment

Provider/oncologist engagement

EXPERIMENTAL

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.

Behavioral: Fit4Treatment

Coaching

EXPERIMENTAL

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.

Behavioral: Fit4Treatment

Interventions

Fit4Treatment BEHAVIORAL

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.

Coaching; Exercise Partner; Provider/oncologist engagement; Symptom burden-tailored goal setting app

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Uterine Cervical Diseases; Vulvar Diseases; Vaginal Diseases; Behavior

Study Officials

• Emma Barber, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Grace, PhD

CONTACT

312-503-4165; anne@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The researchers will use a MOST full factorial study design to optimize the Fit4Treatment physical activity intervention by testing the core intervention of an activity tracker and commercially available app (Fitbit) in addition to four components which are expected to improve physical activity: 1) symptom-burden tailored goal setting app, 2) exercise partner, 3) oncology provider engagement, and 4) coaching calls. Patients will be randomized to 16 groups formed by all possible combinations of these four components in a full factorial design.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 24, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)