NCT02938780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

September 19, 2016

Last Update Submit

January 15, 2020

Conditions

Breast Cancer Female

Keywords

Behavioral economicsBreast cancer survivorsnutritionphysical activity

Outcome Measures

Primary Outcomes (1)

  • Urinary levels of 8-OHdG

    To measure oxidative stress DNA damage. ug/mmol creatinine

    3 months

Secondary Outcomes (4)

  • physical activity

    3 months

  • Intake of fruit and vegetable behavior

    3 months

  • Self-efficacy

    3 months

  • Serum total antioxidant capacity

    3 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

EXPERIMENTAL

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

Interventions

placebo text messageOTHER

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.

Control
nutrition physical activity text messageOTHER

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.

Intervention

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current participation in other treatment (chemo/radiotherapy) clinical trials
  • Instructed by doctor not to exercise
  • Cannot read English
  • Not able to receive text messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Conrad Lyford, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2016

First Posted

October 19, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)