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Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06746428

ACTIVATE A Pilot Randomized Activity Coaching Trial to Increase Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer

Led by Inova Health Care Services · Updated on 2026-03-03

16

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Fatigue is a common side effect for women undergoing pelvic radiation therapy for endometrial cancer, often making daily activities more difficult. While exercise has been recommended to help with fatigue in cancer patients, there is limited research on its role during pelvic radiation therapy. This trial aims to evaluate whether an activity coaching program can improve treatment-related fatigue in women receiving this therapy. Participants will take part in an exercise coaching program involving ten weekly check-ins with a certified exercise coach. They will set weekly activity goals based on what is easy and enjoyable for them, with check-ins available in person or virtually. Participants will be randomly assigned to start the program either immediately during radiation therapy or after radiation therapy has ended, with the study lasting about six months. All participants will receive a Fitbit to monitor activity, heart rate, and steps. Throughout the study, participants will complete four surveys and perform a 6-minute walk test four times to assess heart and lung response to exercise. At the end of the trial, an interview will be conducted to gather feedback on the program. Researchers will monitor adherence to coaching sessions as the primary outcome, along with changes in fatigue, bowel and urinary symptoms, quality of life, cognitive function, sexual function, self-efficacy, and walking distance. The study aims to follow participants for up to 24 months.

CONDITIONS

Brief Title

Activity Coaching During Pelvic Radiation Therapy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Diagnosed with endometrial cancer of any histology, Stage I-IVA
  • Have undergone modified radical or radical hysterectomy
  • Plan to receive pelvic external beam radiation therapy
  • ECOG performance status of 0 or 1
  • Have access to a computer, smartphone, or tablet with internet and email
  • Able to read, understand, and provide written informed consent
  • Cleared by physician for unmonitored exercise based on ability to walk without assistance, absence of cognitive impairment, and low fall risk
  • No need to refrain from any activity
Not Eligible

You will not qualify if you...

  • Unable to schedule and attend coaching visits
  • Currently exercising 150 minutes or more per week at moderate intensity
  • Unable to perform the five-times stand test
  • Medical conditions such as unstable angina, uncontrolled dysrhythmias, acute pulmonary embolus, or active pulmonary infection

Research Team

M

Melissa Miller, PhD

N

Natasha Raja, MS

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