Actively Recruiting
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for consent and eligibility assessment
Duration - 10 weeks per coaching program, timing varies by group assignment
Participants engage in an exercise coaching program tailored to increase activity during and after pelvic radiation therapy. Weekly coaching check-ins with a certified exercise coach are held to set and review activity goals.
10 weekly check-ins (in-person or virtual), scheduled at participant convenience
Duration - Up to 6 months total study participation
Participants continue to be monitored for changes in activity, fatigue, quality of life, and other health outcomes through surveys, 6-minute walk tests, and an interview at the end of the study.
4 surveys and 4 walking tests completed throughout the study, plus 1 final interview
Trial Site Locations
Total: 4 locations
1
Inova Schar Cancer Institute - Alexandria
Alexandria, Virginia, United States, 22311
Actively Recruiting
2
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
3
Inova Schar Cancer Institute - Fair Oaks
Fairfax, Virginia, United States, 22033
Actively Recruiting
4
Inova Schar Cancer Institute - Loudoun
Leesburg, Virginia, United States, 20176
Actively Recruiting
Research Team
M
Melissa Miller, PhD
N
Natasha Raja, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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