MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Behavioral: Tailored Feedback Messages

• Registration Number: NCT03820024
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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 Timeline

• Study Start: 2018-09-28
• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Primary Completion: 2019-12-23
• Study Completion: 2020-12-23
• Results First Submitted: 2021-06-17
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-29
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Feedback Messages	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

North Carolina Cancer Hospital; 🇺🇸 Chapel Hill, North Carolina, United States