Activity Coaching During Pelvic Radiation Therapy (ACTIVATE)
Status
Conditions
Treatments
Details and patient eligibility
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. 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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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At least 18 years of age
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Pathologic diagnosis of endometrial cancer (any histology, Stage I-IVA)
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Has undergone modified radical or radical hysterectomy
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Plan to receive adjuvant treatment with pelvic external beam radiation therapy at ISCI
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ECOG performance status of 0-1
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Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email
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Able to read, understand and provide written informed consent
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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
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Participant does not need to refrain from any activity
Exclusion criteria
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Unable to schedule and attend coaching visits
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Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline
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Unable to perform the five-times stand test
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Medical comorbidities including:
- Unstable angina
- Uncontrolled dysrhythmias
- Acute pulmonary embolus
- Active pulmonary infection
Trial design
Primary purpose
Allocation
Interventional model
Masking
16 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Natasha Raja, MS; Melissa Miller, PhD
Data sourced from clinicaltrials.gov
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