An interventional study of placebo text message and nutrition physical activity text message in Breast Cancer Female, sponsored by Texas Tech University Health Sciences Center. Completed at 1 site in United States. Open to female participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 310 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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 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 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.
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.
Urinary levels of 8-OHdG
To measure oxidative stress DNA damage. ug/mmol creatinine
Time frame: 3 months
physical activity
Use physical activity survey
Time frame: 3 months
Intake of fruit and vegetable behavior
Use food intake record
Time frame: 3 months
Self-efficacy
Use Self-efficacy survey
Time frame: 3 months
Serum total antioxidant capacity
To measure total antioxidant concentration (mM)
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center