MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback

NCT ID: NCT03820024

Last Updated: 2021-07-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2020-12-23

Brief Summary

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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

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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.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Tailored Feedback Messages

Intervention Type 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.

No Messages

No feedback messages

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Clark, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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North Carolina Cancer Hospital

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LCCC 1614

Identifier Type: -

Identifier Source: org_study_id

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