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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: placebo text message; Other: nutrition physical activity text message

• Study Type: Interventional
• Enrollment (Anticipated): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary levels of 8-OHdG	To measure oxidative stress DNA damage. ug/mmol creatinine	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Collaborators: Texas Tech University
• Investigators: Principal Investigator: Conrad Lyford, PhD, Texas Tech University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; nutrition; Breast cancer survivors; Behavioral economics
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: L15-178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO