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

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Other: placebo text message; Other: nutrition physical activity text message

• Registration Number: NCT02938780
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Primary Completion: 2019-09
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Intervention	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.

Primary Outcome Measures

Name	Time	Method
Urinary levels of 8-OHdG	3 months	To measure oxidative stress DNA damage. ug/mmol creatinine

Secondary Outcome Measures

Name	Time	Method
physical activity	3 months	Use physical activity survey
Serum total antioxidant capacity	3 months	To measure total antioxidant concentration (mM)
Intake of fruit and vegetable behavior	3 months	Use food intake record
Self-efficacy	3 months	Use Self-efficacy survey

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States