RECRUITING

Activity Coaching During Pelvic Radiation Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-27
Study Completion:2026-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06746428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
  3. * Has undergone modified radical or radical hysterectomy
  4. * Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
  5. * ECOG performance status of 0-1
  6. * Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email
  7. * Able to read, understand and provide written informed consent
  8. * Deemed appropriate for unmonitored exercise by treating physician based on the following evidence-based criteria (1)
  9. * Walk without any assistance or assistance device
  10. * Absence of significant cognitive impairment
  11. * Absence of high risk for falls
  12. * Participant does not need to refrain from any activity
  1. * Unable to schedule and attend coaching visits
  2. * Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
  3. * Unable to perform the five-times stand test
  4. * Medical comorbidities including:
  5. * Unstable angina
  6. * Uncontrolled dysrhythmias
  7. * Acute pulmonary embolus
  8. * Active pulmonary infection

Contacts and Locations

Study Contact

Melissa Miller, PhD
CONTACT
(571) 472-4724
activate@inova.org
Natasha Raja, MS
CONTACT
activate@inova.org

Principal Investigator

Avani Rao, MD
PRINCIPAL_INVESTIGATOR
Inova Health Care Services

Study Locations (Sites)

Inova Schar Cancer Institute - Alexandria
Alexandria, Virginia, 22311
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States
Inova Schar Cancer Institute - Fair Oaks
Fairfax, Virginia, 22033
United States
Inova Schar Cancer Institute - Loudoun
Leesburg, Virginia, 20176
United States

Collaborators and Investigators

Sponsor: Inova Health Care Services

  • Avani Rao, MD, PRINCIPAL_INVESTIGATOR, Inova Health Care Services

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-27
Study Completion Date2026-02-01

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2026-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Radiation Therapy
  • Gynecologic Cancer
  • Exercise Therapy