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

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ClinicalTrials.gov Identifier: NCT03820024
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Behavioral: Tailored Feedback Messages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: No Messages
No feedback messages



Primary Outcome Measures :
  1. Change in steps in endometrial cancer survivors during 12 week intervention [ Time Frame: 2 years ]
    Steps recorded on a fitness tracker at week 1 and week 13



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820024


Contacts
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Contact: Luz Cuaboy, MS 919-966-7051 luz_cuaboy@med.unc.edu
Contact: Amy Garrett, MA 919-966-0895 amy_garrett@med.unc.edu

Locations
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United States, North Carolina
North Carolina Cancer Hospital Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Leslie Clark, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Leslie Clark, MD UNC Lineberger Comprehensive Cancer Center

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03820024     History of Changes
Other Study ID Numbers: LCCC 1614
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female