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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Physical Activity
Secondary outcome measures
Adverse Events
Change in Anxiety
Change in Fatigue
+10 more

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.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,738 Total Patients Enrolled
4 Trials studying Endometrial Cancer
6,105 Patients Enrolled for Endometrial Cancer
Emma Barber, MD, MSPrincipal InvestigatorNorthwestern University
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Endometrial Cancer
75 Patients Enrolled for Endometrial Cancer

Media Library

Fit4Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05743517 — N/A
Endometrial Cancer Research Study Groups: Provider/oncologist engagement, Coaching, Symptom burden-tailored goal setting app, Exercise Partner
Endometrial Cancer Clinical Trial 2023: Fit4Treatment Highlights & Side Effects. Trial Name: NCT05743517 — N/A
Fit4Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743517 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research program have any vacancies at present?

"As of the time of this writing, clinicaltrials.gov displays that this research is not actively recruiting participants; however, 1198 other studies are currently accepting patients into their trials. The initial listing for this trial was posted on June 1st 2023 and updated most recently on February 21th 2023."

Answered by AI
~128 spots leftby Aug 2028