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OpenTrials
Completed

NCT Number: NCT02938780

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.

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Key information

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo text message

Other

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

Other

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.

Primary outcomes

  1. Urinary levels of 8-OHdG

    Time frame: 3 months

    To measure oxidative stress DNA damage. ug/mmol creatinine

Secondary outcomes

  1. physical activity

    Time frame: 3 months

    Use physical activity survey

  2. Intake of fruit and vegetable behavior

    Time frame: 3 months

    Use food intake record

  3. Self-efficacy

    Time frame: 3 months

    Use Self-efficacy survey

  4. Serum total antioxidant capacity

    Time frame: 3 months

    To measure total antioxidant concentration (mM)

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Collaborators

  • Texas Tech University

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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