Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Study Overview
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Brief Summary
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The investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of Latina breast cancer survivors who have completed breast cancer treatment. Participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control.

Detailed Description
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There are clear diet and physical activity guidelines for cancer survivors: eat a diet high in fruits/vegetables and low in energy-dense foods and engage in 150 minutes of moderate-to-vigorous physical activity each week. However, cancer survivors are provided with few, if any, resources to meet these guidelines and there are limited data supporting how cancer survivors can achieve sustained dietary change. There are even fewer behavioral change resources available to minority cancer survivors. Few studies have examined the separate and synergistic effects of in-person education and electronic or e-communication strategies in changing and maintaining health behaviors.

Official Title
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Mi Vida Saludable: Maintaining Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: In-person education
* Behavioral: E-communication
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female. 21 years of age or older. Self-identify as Hispanic/Latina. Speak Spanish or English. Disease Related Criteria Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease. Prior/ Current Therapy Criteria At least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors). Accessibility Criteria Have access to computer or smartphone. Clinical/ Laboratory Criteria No history of smoking within the past 30 days. No uncontrolled diabetes mellitus defined as Hgb A1C >7% Consume <5 servings of fruits and vegetables per day and/or engages in <150 weekly minutes of moderate to vigorous physical activity. Exclusion Criteria: Any criterion not met under inclusion.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Subjects will receive in-person education plus e-communication AND subjects will receive control intervention | Behavioral: In-person education<br>* Four in-person hands-on nutrition and physical activity education classes and cooking sessions.<br>Behavioral: E-communication<br>* 11 months of motivational text messages, emailed newsletters, and access to a website.<br>Behavioral: Control<br>* Written guidelines on diet and physical activity for breast cancer survivors, a pedometer to encourage physical activity, and a brief verbal overview of diet and physical activity guidelines for cancer survivors.<br>|
| Experimental: Arm B<br>Subjects will receive e-communication alone AND subjects will receive control intervention | Behavioral: E-communication<br>* 11 months of motivational text messages, emailed newsletters, and access to a website.<br>Behavioral: Control<br>* Written guidelines on diet and physical activity for breast cancer survivors, a pedometer to encourage physical activity, and a brief verbal overview of diet and physical activity guidelines for cancer survivors.<br>|
| Experimental: Arm C<br>Subjects will receive in-person education alone AND subjects will receive control intervention | Behavioral: In-person education<br>* Four in-person hands-on nutrition and physical activity education classes and cooking sessions.<br>Behavioral: Control<br>* Written guidelines on diet and physical activity for breast cancer survivors, a pedometer to encourage physical activity, and a brief verbal overview of diet and physical activity guidelines for cancer survivors.<br>|
| Active Comparator: Arm D<br>Subjects will receive control intervention | Behavioral: Control<br>* Written guidelines on diet and physical activity for breast cancer survivors, a pedometer to encourage physical activity, and a brief verbal overview of diet and physical activity guidelines for cancer survivors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily servings of fruit/vegetables | Self-reported habitual fruit and vegetable intake will be assessed using the 10-item National Cancer Institute (NCI) All-Day Fruit and Vegetable screener. | Baseline, 6 months, 12 months | 
| Change in energy density |  | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity | Physical activity will be measured using The International Physical Activity Questionnaire (IPAQ). The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Cancer survivor, e-communication, diet and physical activity, fruits/vegetables daily servings, energy density