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FitEx + Yoga for Endometrial Cancer Survivorship
N/A
Waitlist Available
Led By Shannon Armbruster, MD MPH
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 8 weeks to 6 months (post-intervention)
Awards & highlights
Study Summary
This trial compares physical activity outcomes for cancer survivors in 3 groups: usual care, FitEx, and FitEx+yoga, with surveys & a Fitbit to measure success.
Who is the study for?
This trial is for endometrial cancer survivors with a BMI of 30 or higher, early stage (I-II) diagnosis, internet access, and the ability to consent. They must be adults who understand English well. It's not for those with recurrent cancer, physical limitations that prevent safe participation, or who already meet ACS's physical activity guidelines.Check my eligibility
What is being tested?
The study compares three groups: usual care; FitEx program; and FitEx plus yoga. Participants in the FitEx groups will involve their support team members in activities. The focus is on whether these interventions increase physical activity and improve quality of life among other factors.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like newsletters, self-monitoring tools, group dynamics discussions, and virtual yoga sessions rather than drugs or medical procedures, traditional side effects are not a concern here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 8 weeks to 6 months (post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 8 weeks to 6 months (post-intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
Secondary outcome measures
Flourishing Maintenance- Survivors
Flourishing- Survivors
Habit Formation Maintenance- Survivors
+14 moreOther outcome measures
Flourishing Maintenance- Support team members
Flourishing- Support team members
Habit Formation Maintenance- Support team members
+13 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: FitEx-ECS+ YogaExperimental Treatment4 Interventions
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS+yoga intervention program, with a focus on postures, breathwork, and mindfulness. Fitbits will be given to track physical activity.
Group II: FitEx-ECSExperimental Treatment4 Interventions
Endometrial cancer survivors and their support team members (as a group of one survivor and their team) will complete the FitEx-ECS intervention program, with a focus on walking. Fitbits will be given to track physical activity.
Group III: Usual careActive Control1 Intervention
Endometrial cancer survivors will receive standard survivorship care including a one-time educational newsletter about survivorship physical activity and nutrition recommendations. Fitbits will be given to track physical activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-monitoring
2018
Completed Phase 3
~2280
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityOTHER
141 Previous Clinical Trials
27,616 Total Patients Enrolled
Carilion ClinicLead Sponsor
70 Previous Clinical Trials
12,565 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,429 Total Patients Enrolled
1 Trials studying Endometrial Cancer
28 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My endometrial cancer has come back.I need a walking aid like a walker, wheelchair, or scooter.I was diagnosed with early stage (I or II) endometrial cancer.I am able to understand and willing to sign the consent form.I am able to understand and willing to sign the consent form.My BMI is 30 or higher.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: FitEx-ECS
- Group 3: FitEx-ECS+ Yoga
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical trial that can be filled by participants?
"According to clinicaltrials.gov, this study is not presently recruiting participants having been initially posted on February 1st 2023 and modified two weeks later. However, 1557 other studies are currently seeking out volunteers."
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