NCT06746428 · Inova Health Care Services
Activity Coaching During Pelvic Radiation Therapy
(ACTIVATE)
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Alexandria, Virginia
- Fairfax, Virginia
- Leesburg, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations