Breast Cancer Female
Conditions
Keywords
Behavioral economics, Breast cancer survivors, nutrition, physical activity
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.
Interventions
OTHERplacebo 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.
OTHERnutrition 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.
Sponsors
Texas Tech University
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary levels of 8-OHdG | 3 months | To measure oxidative stress DNA damage. ug/mmol creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical activity | 3 months | Use physical activity survey |
| Intake of fruit and vegetable behavior | 3 months | Use food intake record |
| Self-efficacy | 3 months | Use Self-efficacy survey |
| Serum total antioxidant capacity | 3 months | To measure total antioxidant concentration (mM) |
Countries
United States
Outcome results
None listed