- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820024
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback (MOVES)
July 8, 2021 updated by: UNC Lineberger Comprehensive Cancer Center
The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention.
The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors.
It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objectives:
- To assess if a tailored feedback fitness intervention can increase physical activity in EC survivors from baseline to 12 weeks post-baseline
- To determine the acceptability of the fitness intervention in EC survivors through a completion survey.
- To assess if a tailored feedback message fitness intervention can (1) decrease BMI, (2) reduce waitst to hip (W.H) ratios, (3) improve quality of life (QOL) and (4) improve serum metabolic markers (insulin, glucose and low density lipoprotein (LDL) in EC survivors.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- 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 Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- North Carolina Cancer Hospital
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-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Be over the age of 18 years
- Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months
- Have no current evidence of endometrial cancer
- Have a BMI 25 kg/m2 or greater
- Have approval from their treating physician to engage in moderate-intensity physical activity.
- Have a smart phone with Bluetooth capabilities turned on
- Have access to email
Exclusion Criteria:
- Are currently undergoing treatment for their cancer
- Are unable to read a sample message aloud
- Do not have a computer or smart phone with Bluetooth capabilities
- Are pregnant
- Have a history of angina or palpitations with exertion
- Have a history of uncontrolled pulmonary disease (COPD or asthma)
- Have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored Feedback Messages
Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly based on the CHART algorithm (Appendix 1).
Participants on the feedback arm will receive 1 message per week during the 3-month study period.
|
Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly.
Participants on the feedback arm will receive 1 message per week during the 3-month study period.
|
No Intervention: No Messages
No feedback messages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
Time Frame: 13 weeks
|
Steps recorded on a fitness tracker at week 1 and week 13
|
13 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leslie Clark, MD, UNC Lineberger Comprehensive Cancer Center
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)
September 28, 2018
Primary Completion (Actual)
December 23, 2019
Study Completion (Actual)
December 23, 2020
Study Registration Dates
First Submitted
October 16, 2018
First Submitted That Met QC Criteria
January 24, 2019
First Posted (Actual)
January 29, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC 1614
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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