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Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors

Primary Purpose

Breast Cancer Female

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
placebo text message
nutrition physical activity text message
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Behavioral economics, Breast cancer survivors, nutrition, physical activity

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • Age: 20-75 years old
  • No current pregnancy or lactation
  • Was diagnosed with Stage 0-IIIB disease and completed all local and systemic therapy (including Herceptin) at least 3 months prior to entry. Women can be on or off anti-hormone therapy.
  • Ambulatory
  • Willing to be randomized

Exclusion Criteria:

  • Current participation in other treatment (chemo/radiotherapy) clinical trials
  • Instructed by doctor not to exercise
  • Cannot read English
  • Not able to receive text messages

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

The subjects in the control group will receive placebo text messages which will be timed as the intervention group that are unrelated to the study or topics of exercise and nutrition.

The subjects in the intervention group will receive text messages with nutrition and physical activity-related information throughout the study period on a daily basis, varying text message.

Outcomes

Primary Outcome Measures

Urinary levels of 8-OHdG
To measure oxidative stress DNA damage. ug/mmol creatinine

Secondary Outcome Measures

physical activity
Use physical activity survey
Intake of fruit and vegetable behavior
Use food intake record
Self-efficacy
Use Self-efficacy survey
Serum total antioxidant capacity
To measure total antioxidant concentration (mM)

Full Information

First Posted
September 19, 2016
Last Updated
January 15, 2020
Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT02938780
Brief Title
Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Official Title
Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Preventing or reducing obesity is one factor that has been hailed as a way to improve quality of life, reduce recurrence, and increase survival rates among breast cancer survivors. An experienced team of multi-disciplinary researchers has developed an innovative and unique approach to encourage enhanced nutrition and exercise behaviors in this population using principles of behavioral economics. In particular, the use of social norms or exemplars has been shown in other applications to be effective, and if successful in this population could be inexpensively scaled up for widespread adoption. The proposed pilot study develops a system of text messages for social/mobile media that will provide ongoing reinforcement of desired behavior in breast cancer survivors. These messages would focus on achieving compliance with the expert-developed nutrition and exercise recommendations of the American Cancer Society. In the main study, 310 breast cancer survivors will be randomly placed in intervention and control groups for the 12 week study. Behavior change will be measured using established measures of self-reported behavior. In a sub-study, 60 of the breast cancer survivor participants will also provide blood and urine samples so changes in biomarkers can be assessed. The impact of the study will be measured by biomarkers and self-reported survey responses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Behavioral economics, Breast cancer survivors, nutrition, physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The subjects in the control group will receive placebo text messages which will be timed as the intervention group that are unrelated to the study or topics of exercise and nutrition.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The subjects in the intervention group will receive text messages with nutrition and physical activity-related information throughout the study period on a daily basis, varying text message.
Intervention Type
Other
Intervention Name(s)
placebo text message
Intervention Description
The subjects in the control group will receive placebo text messages which will be timed as the intervention group that are unrelated to the study or topics of exercise and nutrition.
Intervention Type
Other
Intervention Name(s)
nutrition physical activity text message
Intervention Description
The subjects in the intervention group will receive text messages with nutrition and physical activity-related information throughout the study period on a daily basis, varying text message arrival over a 10 am to 7 pm time frame. The American Cancer Society recommends a set of exercise and nutrition behaviors for cancer survivors based upon developed expert evidence. These behaviors have been structured to achieve healthier lifestyles, improve quality of life and reduced mortality. The intervention will provide via text messaging exemplars and social norms designed to improve compliance with this advice.
Primary Outcome Measure Information:
Title
Urinary levels of 8-OHdG
Description
To measure oxidative stress DNA damage. ug/mmol creatinine
Time Frame
3 months
Secondary Outcome Measure Information:
Title
physical activity
Description
Use physical activity survey
Time Frame
3 months
Title
Intake of fruit and vegetable behavior
Description
Use food intake record
Time Frame
3 months
Title
Self-efficacy
Description
Use Self-efficacy survey
Time Frame
3 months
Title
Serum total antioxidant capacity
Description
To measure total antioxidant concentration (mM)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Age: 20-75 years old No current pregnancy or lactation Was diagnosed with Stage 0-IIIB disease and completed all local and systemic therapy (including Herceptin) at least 3 months prior to entry. Women can be on or off anti-hormone therapy. Ambulatory Willing to be randomized Exclusion Criteria: Current participation in other treatment (chemo/radiotherapy) clinical trials Instructed by doctor not to exercise Cannot read English Not able to receive text messages
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad Lyford, PhD
Organizational Affiliation
Texas Tech University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors

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