Activity Coaching During Pelvic Radiation Therapy
Part of paid clinical trials in Alexandria, Virginia.
- Sponsor
- Inova Health Care Services
- Study ID
- NCT06746428
- Status
- Recruiting
Conditions
- Exercise Therapy
- Gynecologic Cancer
- Radiation Therapy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exercise Coaching — BEHAVIORALAn 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.
Study Details
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.
Key Dates
- Start date
- Jan 27, 2025
- Status verified
- Mar 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Immediate Start GroupParticipants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation
- Experimental: Delayed Start GroupParticipants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
Primary Outcome Measure
Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions [ Time Frame: Enrollment to end of follow up, up to 24 months ]
Central Contacts
- Melissa Miller, PhD(571) 472-4724
- Natasha Raja, MS
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Inova Schar Cancer Institute - Alexandria | Alexandria | Virginia | 22311 | Natasha Raja, MS |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | Natasha Raja, MS |
| Inova Schar Cancer Institute - Fair Oaks | Fairfax | Virginia | 22033 | Natasha Raja, MS |
| Inova Schar Cancer Institute - Loudoun | Leesburg | Virginia | 20176 | Melissa Miller, PhD Natasha Raja, MS |
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