An interventional study of Exercise Coaching in Radiation Therapy, Gynecologic Cancer and Exercise Therapy, sponsored by Inova Health Care Services. Active, not recruiting at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Treatment
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.
The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually.
All Participants who agree to join this study will be asked to:
The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.
Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1)
Exclusion Criteria:
Medical comorbidities including:
Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation
Behavioral: Exercise Coaching
Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
Behavioral: Exercise Coaching
An exercise coaching program tailored for women with Stage I-IVA endometrial cancer who have undergone total or modified radical hysterectomy with surgical staging. The intervention targets a total of 8 participants who are planned to complete pelvic external beam radiation therapy as part of their adjuvant treatment.
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported fatigue
Measurement of changes in the level of fatigue as reported by patients, using a Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue. FACIT-F fatigue subscale consists of 13 items. Patients rate the intensity of their fatigue symptoms on a scale of 0 to 4 (0=not at all and 4=very much). Total FACIT-F fatigue subscale score ranges from 0 to 52 with higher scores less fatigue and lower scores more fatigue
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported bowel/urinary toxicity
Assessment of changes in the severity of bowel and urinary toxicity symptoms, as reported by patients, using Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary short form assessments. The EPIC-15 is a short-form version that includes 15 items across two domains: Urinary Function and Bowel Habits. Each item in the EPIC-15 is scored on a Likert scale, and the scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported Quality of Life (QOL)
Measurement of changes in the quality of life based on patient-reported outcomes, using Patient-Reported Outcomes Measurement Information System (PROMIS-29) Profile v2.1. It includes 29 items that assess seven key areas: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles/Activities and Pain Interference. Each question usually has five response options ranging in value from one to five. The scores are then converted to T-scores using a scoring table. Higher T-Scores for Physical Function indicate better physical functioning, Higher T-Scores for Anxiety and Depression indicate more severe symptoms. Higher T-Scores for Fatigue and Sleep Disturbance indicate more fatigue or sleep problems. Higher T-Scores in ability to participate in social roles/activities indicate better ability to participate in social roles and activities. Higher T-Scores for Pain Interference means more interference from pain in daily activities and intense pain
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported cognitive function
Evaluation of cognitive function changes reported by patients, measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form 4a. This form contains 4 items. Each item is scored on a Likert scale from 1 (Never) to 5 (Very often). Raw scores are converted to T-scores using a scoring table. Higher T-scores indicate better cognitive function.
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported sexual function and satisfaction
Changes in sexual function and satisfaction, as reported by patients, using a Patient-Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction. Each item is scored on a Likert scale, and then converted into a T-Score. Higher T-scores indicate better sexual function and satisfaction.
Time frame: Enrollment to end of follow up, up to 24 months
Change in patient-reported self-efficacy
Measurement of changes in patients' perceived self-efficacy, using Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Chronic Conditions. Each item is scored on a Likert scale, and then converted into a T-Score. Higher T-scores indicate greater self-efficacy.
Time frame: Enrollment to end of follow up, up to 24 months
Change in distance walked during the 6-Minute Walk Test (6MWT)
Measurement of the change in distance walked by patients during the 6-Minute Walk Test, a standardized test used to assess physical function.
Time frame: Enrollment to end of follow up, up to 24 months
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Plan to share: Yes
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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