Activity Coaching During Pelvic Radiation Therapy

NCT06746428 | Recruiting

• 1 other identifier: INOVA-2024-91
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Radiation Therapy; Gynecologic Cancer; Exercise Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions

  Participant adherence to coaching sessions will be defined as complete adherence when engaging in 10 of the 10 planned exercise coaching sessions and high adherence as engaging in at least 7 of the planned 10 exercise coach check-ins. Participant adherence will be considered feasible if 70% of participants adhere to the coaching sessions.

  Enrollment to end of follow up, up to 24 months

Secondary Outcomes (7)

• Change in patient-reported fatigue

  Enrollment to end of follow up, up to 24 months

• Change in patient-reported bowel/urinary toxicity

  Enrollment to end of follow up, up to 24 months

• Change in patient-reported Quality of Life (QOL)

  Enrollment to end of follow up, up to 24 months

• Change in patient-reported cognitive function

  Enrollment to end of follow up, up to 24 months

• Change in patient-reported sexual function and satisfaction

  Enrollment to end of follow up, up to 24 months

Study Arms (2)

Immediate Start Group

EXPERIMENTAL

Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation

Behavioral: Exercise Coaching

Delayed Start Group

EXPERIMENTAL

Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.

Behavioral: Exercise Coaching

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.

Delayed Start Group; Immediate Start Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (4)

Inova Schar Cancer Institute - Alexandria

Alexandria, Virginia, 22311, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Inova Schar Cancer Institute - Fair Oaks

Fairfax, Virginia, 22033, United States

RECRUITING

Inova Schar Cancer Institute - Loudoun

Leesburg, Virginia, 20176, United States

RECRUITING

Study Officials

• Avani Rao, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Miller, PhD

CONTACT

(571) 472-4724; activate@inova.org

Natasha Raja, MS

CONTACT

activate@inova.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will either be randomized to the Immediate Start Group or to the Delayed Start Group. Participants in the: * Immediate Start Group: Sessions with the exercise coach will start during the first week of participants' radiation therapy, concurrently with radiation treatment and continue post-radiation. * Delayed Start Group: Sessions with the exercise coach will start 6-8 weeks after participants have completed radiation and continue 16-19 weeks post-radiation.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4)