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

Sponsor
Texas Tech University Health Sciences Center (Other)
Overall Status
Completed
CT.gov ID
NCT02938780
Collaborator
Texas Tech University (Other)
310
1
2
54
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: placebo text message
  • Other: nutrition physical activity text message
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
310 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Using Behavioral Economics to Achieve Improved Healthy Behavior Outcomes in Breast Cancer Survivors
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Urinary levels of 8-OHdG [3 months]

    To measure oxidative stress DNA damage. ug/mmol creatinine

Secondary Outcome Measures

  1. physical activity [3 months]

    Use physical activity survey

  2. Intake of fruit and vegetable behavior [3 months]

    Use food intake record

  3. Self-efficacy [3 months]

    Use Self-efficacy survey

  4. Serum total antioxidant capacity [3 months]

    To measure total antioxidant concentration (mM)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Tech University Health Sciences Center Lubbock Texas United States 79430

Sponsors and Collaborators

  • Texas Tech University Health Sciences Center
  • Texas Tech University

Investigators

  • Principal Investigator: Conrad Lyford, PhD, Texas Tech University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT02938780
Other Study ID Numbers:
  • L15-178
First Posted:
Oct 19, 2016
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Texas Tech University Health Sciences Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2020