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Exercise Program for Gynecologic Cancer

N/A

Recruiting

Led By Emma Barber, MD, MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing or planning to undergo any systemic treatment for a gynecologic malignancy (e.g., chemotherapy, immunotherapy, anti-angiogenic therapies, targeted therapies, etc.)

Diagnosis of endometrial/uterine, ovarian, cervical or vulvar/vaginal cancer

Must not have

Cognitive or functional limitations that preclude a patient's ability to participate in the physical activity intervention

Active brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how exercise can improve quality of life and cancer-specific survival in older gynecologic cancer patients using apps, activity trackers, and coaching.

Who is the study for?

This trial is for women over 60 with gynecologic cancers (endometrial/uterine, ovarian, cervical, vulvar/vaginal) who are fluent in English and undergoing systemic treatments like chemotherapy. They should be able to participate in physical activities and find an exercise partner if needed.

What is being tested?

The Fit4Treatment study tests a core intervention using a wearable activity tracker and app, plus four additional components: a symptom-burden tailored app, an exercise partner's involvement, oncology provider engagement, and coaching to boost physical activity.

What are the potential side effects?

Since the intervention focuses on increasing physical activity through non-invasive means such as apps and trackers rather than medication or surgery, side effects may include typical exercise-related issues like muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving or planning to receive treatment for a gynecologic cancer.

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I have been diagnosed with a type of gynecological cancer.

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I am a woman older than 60.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive or physical limitations that prevent me from participating in physical activities.

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I have active cancer spread to my brain.

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I do not have uncontrolled heart disease or other major health issues preventing physical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Physical Activity

Secondary study objectives

Adverse Events

Change in Anxiety

Change in Fatigue

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Symptom burden-tailored goal setting appExperimental Treatment1 Intervention

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 II: Provider/oncologist engagementExperimental Treatment1 Intervention

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 III: Exercise PartnerExperimental Treatment1 Intervention

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 IV: CoachingExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met