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

NCT ID: NCT05743517

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2029-08-01

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.

Detailed Description

Gynecologic cancers include ovarian, uterine and cervical cancers and represent 102,000 cases of cancer in the United States every year; 60% occur in women greater than age 60. Older patients with gynecologic cancers have higher rates of advanced stage at presentation, more aggressive histology and more commonly require adjuvant treatment with systemic therapies such as chemotherapy, immunotherapy or targeted therapies. This chemotherapy, as well as underlying cancer, cause accelerated aging and toxicity, leaving women vulnerable to functional decline, increased frailty, decreased health related quality of life, and ultimately, less systemic therapy completion and inferior cancer survival.

Physical activity has been shown to improve functional health, improve quality of life, slow aging, and decrease rates of frailty. In fact, physical activity, and the multi-system health benefits that result, is the most recommended frailty intervention. Physical activity interventions in cancer survivors reduce sedentary time, decrease functional decline, and lower mortality. Studies specific to patients on active cancer treatment are less common, however, several randomized trials have found less decline in cardiorespiratory fitness, less chemotherapy toxicity, and fewer chemotherapy dose reductions. Although older adults with gynecologic cancer have a high likelihood of benefit from physical activity, challenges exist in accessing current interventions. Traditional in-person strenuous physical activity interventions with static goals may not be appropriate for older women undergoing chemotherapy, where symptom burden is high and varied, and healthcare visits frequent.

Remotely delivered mobile health (mHealth) technology-based physical activity interventions increase physical activity in diverse populations including those with metastatic cancer. Four evidence-based strategies to increase physical activity have demonstrated efficacy in cancer patients and older adults, including, 1) symptom burden tailored goal setting 2) exercise partners 3) oncology provider engagement and 4) coaching. This study will determine which components of a physical activity intervention (Fit4Treatment) meaningfully contribute to improving physical activity (steps) among older women with gynecologic cancer receiving systemic treatment such as chemotherapy.

Conditions

Ovary Cancer; Endometrial Cancer; Uterine Cancer; Cervical Cancer; Cervix Cancer; Vulvar Cancer; Vaginal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fit4Treatment

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Fit4Treatment

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Fit4Treatment

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Fit4Treatment

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Emma Barber

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma Barber, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne Grace, PhD

Role: CONTACT

anne@northwestern.edu

312-503-4165

Facility Contacts

Anne Grace, PhD

Role: primary

anne@northwestern.edu

3125034165

Brenda Vega

Role: backup

brenda.vega@northwestern.edu

Other Identifiers

STU00218257

Identifier Type: -

Identifier Source: org_study_id