FitEx for Endometrial Cancer Survivors: Initial Efficacy

April 23, 2025 updated by: Shannon Armbruster, Carilion Clinic

The Initial Efficacy of FitEx for Endometrial Cancer Survivors: A Pilot Randomized Controlled Trial of a Walking Promotion Program With or Without Yoga

The goal of this clinical trial is to compare physical activity outcomes between endometrial cancer survivors randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3) FitEx+yoga. Survivors randomized to FitEx groups will recruit ~3 support team members to complete the intervention with them. The main question[s] it aims to answer are:

  • Do FitEx groups undertake more physical activity than the usual care group?
  • Are there differences in quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation, and fruit /vegetable consumption

Participants will:

  • Wear a Fitbit
  • Complete surveys
  • Participate in 30 minute weekly virtual meetings (FitEx groups only)
  • Receive weekly newsletters (FitEx groups only)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this pilot study is to evaluate the initial efficacy of FitEx, a physical activity tracking and promotion program, and FitEx+yoga for endometrial cancer survivors (ECS), with focus on improvement of moderate-vigorous physical activity (MVPA) at the completion of the 8-week program. Specifically, this project will recruit early stage ECS with obesity to be randomized to 1 of 3 conditions: 1) usual care, 2) FitEx, 3) FitEx+yoga. ECS in either intervention condition will each select ~3 friends or family members to be their support members (minimum 2 and maximum 5). All ECS will receive a Fitbit to track their MVPA. We will then compare secondary ECS outcome measures between intervention and control groups including quality of life, self-compassion, flourishing, self-efficacy, social support, habit formation and fruit/vegetable consumption. Additionally, support team member MVPA (via Fitbit) and secondary outcomes will be compared. We will also explore long-term MPVA and secondary outcomes in all groups at 6 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

SURIVIVOR

  • Diagnosed with early stage (I-II) endometrial cancer, any histology
  • Received cancer care at Carilion Clinic after 1/1/2010
  • At least 18 years of age
  • Have adequate comprehension (reading and writing) of the English language
  • Have a BMI ≥ 30 kg/m^2 at screening
  • Have stable internet access or access to a smartphone with internet capabilities
  • Meet the requirements of the Physical Activity Readiness Questionnaire(PARQ)
  • Have the capacity to provide informed consent and are willing to provide informed consent
  • SUPPORT TEAM--
  • Were identified by a participant with endometrial cancer as a member of their support system
  • Are at least 18 years of age
  • Have adequate comprehension (reading and writing) of the English language
  • Have stable internet access or access to a smartphone with internet capabilities
  • Meet the requirements of the Physical Activity Readiness Questionnaire (PARQ)
  • Have the capacity to provide informed consent and are willing to provide informed consent

Exclusion Criteria:

SURVIVOR

  • Recurrent endometrial cancer
  • Meeting physical activity guidelines set forth by the American Cancer Society at screening (greater than 150 minutes/week of moderate physical activity, or greater than 75 minutes/week of vigorous physical activity)
  • SUPPORT TEAM: Have functional limitations requiring a walker, wheelchair, scooter, or other walking aid which limits their capacity to engage in the intervention safely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual care
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.
Experimental: FitEx-ECS
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.
Behavioral: Self-monitoring
Tracking physical activity and fruit/vegetable intake.
Behavioral: Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Behavioral: Weekly virtual sessions- Standard
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of physical activity.
Behavioral: Newsletters- Standard
Weekly newsletters support attainment of physical activity and nutrition goals.
Experimental: FitEx-ECS+ Yoga
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.
Behavioral: Self-monitoring
Tracking physical activity and fruit/vegetable intake.
Behavioral: Group-dynamics
Survivors act as team captains, facilitating interactions between themselves and their support team members and providing goal directed feedback.
Behavioral: Newsletters- Yoga
Weekly newsletters support attainment of physical activity and nutrition goals, while including mindfulness principles.
Behavioral: Weekly virtual sessions- Yoga
Weekly 30 minute virtual sessions include support group/team building sessions and 15 minutes of yoga.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits (continuous tracking) between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
Change from baseline to 8 weeks (post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial (FACT-En)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life
Change from baseline to 8 weeks (post-intervention)
Servings of Daily Fruits and Vegetables Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Change from 8 weeks to 6 months (post-intervention)
Servings of Daily Fruits and Vegetables- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Change from baseline to 8 weeks (post-intervention)
Flourishing- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Change from baseline to 8 weeks (post-intervention)
Yoga Self-Efficacy- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: (12-108) higher scores indicate higher efficacy for yoga
Change from baseline to 8 weeks (post-intervention)
Social Support- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: higher numbers indicate more support
Change from baseline to 8 weeks (post-intervention)
Self-compassion- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: (1, 5) with higher scores indicating more self-compassion
Change from baseline to 8 weeks (post-intervention)
Habit Formation- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring (1,7), higher scores indicate more automaticity/habit formation
Change from baseline to 8 weeks (post-intervention)
Moderate to Vigorous Physical Activity of Endometrial Cancer Survivors- Maintenance
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups and usual care (FitEx-ECS vs. control and FitEx-ECS+yoga vs. control)
Change from 8 weeks to 6 months (post-intervention)
Quality of Life Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in quality of life (measured via Functional Assessment of Cancer Therapy - Endometrial) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: physical well-being (0-28), social well-being (0-28), emotional well-being (0-28), functional well-being (0-28), endometrial cancer sub-scale (0-64); higher scores indicate better quality of life
Change from 8 weeks to 6 months (post-intervention)
Flourishing Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in flourishing (measured via The Flourishing Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Change from 8 weeks to 6 months (post-intervention)
Yoga Self-Efficacy Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: (12-108) higher scores indicate higher efficacy for yoga
Change from 8 weeks to 6 months (post-intervention)
Social Support Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: higher numbers indicate more support
Change from 8 weeks to 6 months (post-intervention)
Self-compassion Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF) ) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: (1, 5) with higher scores indicating more self-compassion
Change from 8 weeks to 6 months (post-intervention)
Habit Formation Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)

Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring (1,7), higher scores indicate more automaticity/habit formation
Change from 8 weeks to 6 months (post-intervention)
Physical Activity Level (Active or Insufficiently Active) Maintenance- Survivors
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).
Change from 8 weeks to 6 months (post-intervention)
Physical Activity Level (Active or Insufficiently Active)- Survivors
Time Frame: Change from baseline to 8 weeks (post-intervention)

Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention and usual care conditions (FitEx-ECS versus control and FitEx-ECS+yoga versus control).

Scoring: responses are categorical
Change from baseline to 8 weeks (post-intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moderate to Vigorous Physical Activity- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Change from baseline to 8 weeks (post-intervention)
Moderate to Vigorous Physical Activity Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Among survivors, compare changes in objective moderate-vigorous physical activity (MVPA) obtained from FitBits between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Change from 8 weeks to 6 months (post-intervention)
Flourishing- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Change from baseline to 8 weeks (post-intervention)
Flourishing Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in flourishing (measured via The Flourishing Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: 0-10, with higher scores indication more satisfaction/flourishing
Change from 8 weeks to 6 months (post-intervention)
Yoga Self-Efficacy- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga
Change from baseline to 8 weeks (post-intervention)
Yoga Self-Efficacy Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in yoga self-efficacy (measured via the Yoga Self-Efficacy Scale) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (12-108) higher scores indicate higher efficacy for yoga
Change from 8 weeks to 6 months (post-intervention)
Social Support- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support
Change from baseline to 8 weeks (post-intervention)
Social Support Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in social support (measured via the Sallis Social Support for Exercise Survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: higher numbers indicate more support
Change from 8 weeks to 6 months (post-intervention)
Self-compassion- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion
Change from baseline to 8 weeks (post-intervention)
Self-compassion Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in self-compassion (measured via the Neff 12 item Self-Compassion Scale Short Form (SCS-SF)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring: (1, 5) with higher scores indicating more self-compassion
Change from 8 weeks to 6 months (post-intervention)
Habit Formation- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation
Change from baseline to 8 weeks (post-intervention)
Physical Activity Level (Active or Insufficiently Active)- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Change from baseline to 8 weeks (post-intervention)
Physical Activity Level (Active or Insufficiently Active) Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in national physical activity goal attainment (measured via The Stanford Leisure-Time Activity Categorical Item (L-Cat)) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Change from 8 weeks to 6 months (post-intervention)
Habit Formation Maintenance- Support Team Members
Time Frame: Change from 8 weeks to 6 months (post-intervention)
Examine the change in habit formation around exercise (measured via Self-Reported Behavior Automaticity Index) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga) Scoring (1,7), higher scores indicate more automaticity/habit formation
Change from 8 weeks to 6 months (post-intervention)
Servings of Daily Fruits and Vegetables- Support Team Members
Time Frame: Change from baseline to 8 weeks (post-intervention)
Examine the change in fruit/vegetable intake (measured via Behavioral Risk Factor Surveillance System (BRFSS F/V) survey) between intervention groups (FitEx-ECS vs. FitEx-ECS+yoga)
Change from baseline to 8 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carilion Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
Virginia Polytechnic Institute and State University
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shannon Armbruster, MD MPH, Carilion Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-22-1727
  • UL1TR003015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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