MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

Endometrial Cancer Clinical Trial

— MOVES  

Official title:

The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820024
• Other study ID #: LCCC 1614
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: December 23, 2020

Study information

• Verified date: July 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Behavioral:
• Tailored Feedback Messages
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.

Locations

Country	Name	City	State
United States	North Carolina Cancer Hospital	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention	Steps recorded on a fitness tracker at week 1 and week 13	13 weeks