Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exercise Therapy | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immediate Start Group
- description
- Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation
- interventionNames
- Behavioral: Exercise Coaching
- type
- EXPERIMENTAL
- label
- Delayed Start Group
- description
- Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
- interventionNames
- Behavioral: Exercise Coaching
Primary outcomes (1)
- measure
- Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available