Brief Title
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Official Title
The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Brief Summary
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.
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
Primary Outcome
Change in steps in endometrial cancer survivors during 12 week intervention
Condition
Endometrial Cancer
Intervention
Tailored Feedback Messages
Study Arms / Comparison Groups
Tailored Feedback Messages
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
39
Start Date
September 28, 2018
Completion Date
December 2020
Primary Completion Date
December 23, 2019
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Leslie Clark, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03820024
Organization ID
LCCC 1614
Responsible Party
Sponsor
Study Sponsor
UNC Lineberger Comprehensive Cancer Center
Study Sponsor
Leslie Clark, MD, Principal Investigator, UNC Lineberger Comprehensive Cancer Center
Verification Date
April 2020