Activity Coaching During Pelvic Radiation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Coaching.
- Who it may be relevant to
- Registry conditions: Radiation Therapy, Gynecologic Cancer, Exercise Therapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ACTIVATE: A Pilot Randomized Activity Coaching Trial to Increase Vitality and Energy During Post-operative Pelvic Radiation Therapy for Endometrial Cancer
Overview
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.
Detailed description
The exercise coaching program is a program in which Participants will have ten weekly check-ins with a certified exercise coach. During check-ins, Participants and the exercise coach will set weekly goals. Participants will try to incorporate activities that are easy and enjoyable for them. These visits can be scheduled at their convenience and choose whether these check-ins will be in-person, or virtually.
All Participants who agree to join this study will be asked to:
* Participate in a program with an exercise coach to set weekly goals for activity. The timing of when the program will start will be based on the group Participants are assigned to. * Receive a Fitbit to track how active they are, their heart rate and how many steps they've have taken. * Complete 4 surveys which will be given throughout the course of the study. * Complete a short 6-minute walking test to see how their heart and lungs respond to exercise. This test will be completed 4 times throughout the study. * Participate in an interview with the principal investigator at the end of the study for feedback on how the study can be improved.
The study team expects to enroll 16 patients in this study. Participants will either be placed in the Immediate Start Activity Coaching Program or the Delayed Start Activity Coaching Program. 8 patients will be assigned to the Immediate Start Group, and 8 will be assigned to the Delayed Start Group. Participants will spend about 6 months in this study.
Interventions
- Behavioral Exercise 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.
Primary outcome measures
- Feasibility of a Randomized Trial: Participant Adherence to Exercise Coaching Sessions [Time frame: Enrollment to end of follow up, up to 24 months]
Secondary outcome measures (7)
- Change in patient-reported fatigue [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in patient-reported bowel/urinary toxicity [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in patient-reported Quality of Life (QOL) [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in patient-reported cognitive function [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in patient-reported sexual function and satisfaction [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in patient-reported self-efficacy [Time frame: Enrollment to end of follow up, up to 24 months]
- Change in distance walked during the 6-Minute Walk Test (6MWT) [Time frame: Enrollment to end of follow up, up to 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Inova Schar Cancer Institute - Alexandria — Alexandria
- Inova Schar Cancer Institute — Fairfax
- Inova Schar Cancer Institute - Fair Oaks — Fairfax
- Inova Schar Cancer Institute - Loudoun — Leesburg
Identifiers
NCT: NCT06746428 · INOVA-2024-91