Clinical trial NCT02938780: Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Official title: Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Behavioral economics
Breast cancer survivors
nutrition
physical activity
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: Texas Tech University
First posted: 2016-10-19
Enrollment: 310
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Urinary levels of 8-OHdG
timeFrame: 3 months
Secondary outcomes:
measure: physical activity
timeFrame: 3 months
measure: Intake of fruit and vegetable behavior
timeFrame: 3 months
measure: Self-efficacy
timeFrame: 3 months
measure: Serum total antioxidant capacity
timeFrame: 3 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University
name: Conrad Lyford, PhD
role: PRINCIPAL_INVESTIGATOR
References: