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OpenTrials
Completed

NCT Number: NCT03820024

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tailored Feedback Messages

Behavioral

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Acronym: MOVES

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 29, 2019
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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