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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
Inova Schar Cancer Institute - Alexandria
RECRUITING
Alexandria
Inova Schar Cancer Institute
RECRUITING
Fairfax
Inova Schar Cancer Institute - Fair Oaks
RECRUITING
Fairfax
Inova Schar Cancer Institute - Loudoun
RECRUITING
Leesburg
Contact Information
Primary
Melissa Miller, PhD
activate@inova.org
(571) 472-4724
Backup
Natasha Raja, MS
activate@inova.org
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 16
Treatments
Experimental: Immediate Start Group
Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation
Experimental: Delayed Start Group
Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
Related Therapeutic Areas
Sponsors
Leads: Inova Health Care Services

This content was sourced from clinicaltrials.gov