NCT06746428

Activity Coaching During Pelvic Radiation Therapy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually. All Participants who agree to join this study will be asked to: * Participate in a program with an exercise coach to set weekly goals for activity. The timing of when the program will start will be based on the group Participants are assigned to. * Receive a Fitbit to track how active they are, their heart rate and how many steps they've have taken. * Complete 4 surveys which will be given throughout the course of the study. * Complete a short 6-minute walking test to see how their heart and lungs respond to exercise. This test will be completed 4 times throughout the study. * Participate in an interview with the principal investigator at the end of the study for feedback on how the study can be improved. The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.

Conditions

• Radiation Therapy
• Gynecologic Cancer
• Exercise Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Coaching	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.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-12-24
• Last updated: 2026-03-03

Locations

4 sites across 1 country: United States