Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2025-01-27
2026-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants in the:
* Immediate Start Group: Sessions with the exercise coach will start during the first week of participants' radiation therapy, concurrently with radiation treatment and continue post-radiation.
* Delayed Start Group: Sessions with the exercise coach will start 6-8 weeks after participants have completed radiation and continue 16-19 weeks post-radiation.
TREATMENT
NONE
Study Groups
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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
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.
Delayed Start Group
Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Inova Health Care Services
OTHER
Responsible Party
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Principal Investigators
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Avani Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Health Care Services
Locations
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Inova Schar Cancer Institute - Alexandria
Alexandria, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Inova Schar Cancer Institute - Fair Oaks
Fairfax, Virginia, United States
Inova Schar Cancer Institute - Loudoun
Leesburg, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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INOVA-2024-91
Identifier Type: -
Identifier Source: org_study_id
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