Activity coaching for women undergoing pelvic radiation therapy
ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
This study tests if an activity coaching program can help women with endometrial cancer feel better and manage fatigue while they are receiving pelvic radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Inova Health Care Services Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Alexandria, Virginia and 3 other locations) |
| Trial ID | NCT06746428 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an activity coaching program for women receiving pelvic radiation therapy for endometrial cancer. Participants will engage in ten weekly check-ins with a certified exercise coach to set and achieve personalized activity goals. They will receive a Fitbit to monitor their activity levels and complete surveys and walking tests throughout the study. The program is designed to help alleviate treatment-related fatigue and improve overall well-being during therapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of endometrial cancer who are scheduled to receive pelvic radiation therapy.
Not a fit: Patients who are already engaged in a regular exercise program of 150 minutes or more per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce fatigue and improve the quality of life for women undergoing pelvic radiation therapy.
How similar studies have performed: While there is existing research on exercise for cancer-related fatigue, this specific approach focusing on pelvic radiation therapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age * Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA) * Has undergone modified radical or radical hysterectomy * Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI * ECOG performance status of 0-1 * Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email * Able to read, understand and provide written informed consent * Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1) * Walk without any assistance or assistance device * Absence of significant cognitive impairment * Absence of high risk for falls * Participant does not need to refrain from any activity Exclusion Criteria: * Unable to schedule and attend coaching visits * Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline * Unable to perform the five-times stand test * Medical comorbidities including: * Unstable angina * Uncontrolled dysrhythmias * Acute pulmonary embolus * Active pulmonary infection
Where this trial is running
Alexandria, Virginia and 3 other locations
- Inova Schar Cancer Institute - Alexandria — Alexandria, Virginia, United States (Recruiting)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
- Inova Schar Cancer Institute - Fair Oaks — Fairfax, Virginia, United States (Recruiting)
- Inova Schar Cancer Institute - Loudoun — Leesburg, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Avani Rao, MD — Inova Health Care Services
- Study coordinator: Melissa Miller, PhD
- Email: activate@inova.org
- Phone: (571) 472-4724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.