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 — BEHAVIORAL
    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.

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 Group
    Participants 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 Group
    Participants 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

Locations (4)

FacilityCityStateZIPSite coordinators
Inova Schar Cancer Institute - AlexandriaAlexandriaVirginia22311
Melissa Miller, PhD
571-472-4724
Natasha Raja, MS
Inova Schar Cancer InstituteFairfaxVirginia22031
Melissa Miller, PhD
571-472-4724
Natasha Raja, MS
Inova Schar Cancer Institute - Fair OaksFairfaxVirginia22033
Melissa Miller, PhD
571-472-4724
Natasha Raja, MS
Inova Schar Cancer Institute - LoudounLeesburgVirginia20176
Melissa Miller, PhD
Natasha Raja, MS

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