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

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ClinicalTrials.gov Identifier: NCT02938780
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Texas Tech University
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Other: placebo text message Other: nutrition physical activity text message Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Study Start Date : June 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
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.
Other: placebo text message
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.

Experimental: Intervention
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.
Other: nutrition physical activity text message
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 Measures :
  1. Urinary levels of 8-OHdG [ Time Frame: 3 months ]
    To measure oxidative stress DNA damage. ug/mmol creatinine


Secondary Outcome Measures :
  1. physical activity [ Time Frame: 3 months ]
    Use physical activity survey

  2. Intake of fruit and vegetable behavior [ Time Frame: 3 months ]
    Use food intake record

  3. Self-efficacy [ Time Frame: 3 months ]
    Use Self-efficacy survey

  4. Serum total antioxidant capacity [ Time Frame: 3 months ]
    To measure total antioxidant concentration (mM)



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02938780


Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Texas Tech University
Investigators
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Principal Investigator: Conrad Lyford, PhD Texas Tech University

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02938780     History of Changes
Other Study ID Numbers: L15-178
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Texas Tech University Health Sciences Center:
Behavioral economics
Breast cancer survivors
nutrition
physical activity

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases