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MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback (MOVES)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Feedback Messages
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • North Carolina Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tailored Feedback Messages

No Messages

Arm 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.

No feedback messages

Outcomes

Primary Outcome Measures

Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
Steps recorded on a fitness tracker at week 1 and week 13

Secondary Outcome Measures

Full Information

First Posted
October 16, 2018
Last Updated
July 8, 2021
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03820024
Brief Title
MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Acronym
MOVES
Official Title
The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Feedback Messages
Arm Type
Experimental
Arm 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.
Arm Title
No Messages
Arm Type
No Intervention
Arm Description
No feedback messages
Intervention Type
Behavioral
Intervention Name(s)
Tailored Feedback Messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
Description
Steps recorded on a fitness tracker at week 1 and week 13
Time Frame
13 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Clark, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Cancer Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

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