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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

Tracking Information
First Submitted Date  ICMJE September 19, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date January 8, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Urinary levels of 8-OHdG [ Time Frame: 3 months ]
To measure oxidative stress DNA damage. ug/mmol creatinine
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02938780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • physical activity [ Time Frame: 3 months ]
    Use physical activity survey
  • Intake of fruit and vegetable behavior [ Time Frame: 3 months ]
    Use food intake record
  • Self-efficacy [ Time Frame: 3 months ]
    Use Self-efficacy survey
  • Serum total antioxidant capacity [ Time Frame: 3 months ]
    To measure total antioxidant concentration (mM)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Official Title  ICMJE Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer Female
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: placebo text message
  • 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.
    Intervention: Other: nutrition physical activity text message
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
310
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938780
Other Study ID Numbers  ICMJE L15-178
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Texas Tech University Health Sciences Center
Study Sponsor  ICMJE Texas Tech University Health Sciences Center
Collaborators  ICMJE Texas Tech University
Investigators  ICMJE
Principal Investigator: Conrad Lyford, PhD Texas Tech University
PRS Account Texas Tech University Health Sciences Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP