RecruitingNot ApplicableNCT06746428

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


Sponsor

Inova Health Care Services

Enrollment

16 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • 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 Criteria8

  • 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

Interventions

BEHAVIORALExercise 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.


Locations(4)

Inova Schar Cancer Institute - Alexandria

Alexandria, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Inova Schar Cancer Institute - Fair Oaks

Fairfax, Virginia, United States

Inova Schar Cancer Institute - Loudoun

Leesburg, Virginia, United States

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NCT06746428


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