RecruitingNot Applicable

Activity Coaching During Pelvic Radiation Therapy

United States16 participantsStarted 2025-01-27

Plain-language summary

Research has shown that for women who are undergoing pelvic radiation therapy, fatigue is a common side effect. Fatigue that occurs during radiation therapy can make it harder to perform daily living activities. While there are studies that recommend exercise as a treatment for fatigue in cancer patients and survivors, there are currently no studies that focus on the role of exercise for women undergoing pelvic radiation therapy. The purpose of this study is to see if incorporating an activity coaching program is helpful in improving treatment-related fatigue for women undergoing pelvic radiation therapy for endometrial cancer.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years of age * Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA) * Has undergone modified radical or radical hysterectomy * Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI * ECOG performance status of 0-1 * Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email * Able to read, understand and provide written informed consent * Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1) * Walk without any assistance or assistance device * Absence of significant cognitive impairment * Absence of high risk for falls * Participant does not need to refrain from any activity Exclusion Criteria: * Unable to schedule and attend coaching visits * Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline * Unable to perform the five-times stand test * Medical comorbidities including: * Unstable angina * Uncontrolled dysrhythmias * Acute pulmonary embolus * Active pulmonary infection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions

Timeframe: Enrollment to end of follow up, up to 24 months

Trial details

NCT IDNCT06746428

SponsorInova Health Care Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Melissa Miller, PhD

(571) 472-4724 activate@inova.org

View on ClinicalTrials.gov More Radiation Therapy trials