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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938780
• Other study ID #: L15-178
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary levels of 8-OHdG	To measure oxidative stress DNA damage. ug/mmol creatinine	3 months
Secondary	physical activity	Use physical activity survey	3 months
Secondary	Intake of fruit and vegetable behavior	Use food intake record	3 months
Secondary	Self-efficacy	Use Self-efficacy survey	3 months
Secondary	Serum total antioxidant capacity	To measure total antioxidant concentration (mM)	3 months