Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-09-11

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.

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COMPLETED PHASE2

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm A

Subjects will receive in-person education plus e-communication AND subjects will receive control intervention

Group Type EXPERIMENTAL

In-person education

Intervention Type BEHAVIORAL

Four in-person hands-on nutrition and physical activity education classes and cooking sessions.

E-communication

Intervention Type BEHAVIORAL

11 months of motivational text messages, emailed newsletters, and access to a website.

Control

Intervention Type BEHAVIORAL

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.

Arm B

Subjects will receive e-communication alone AND subjects will receive control intervention

Group Type EXPERIMENTAL

E-communication

Intervention Type BEHAVIORAL

11 months of motivational text messages, emailed newsletters, and access to a website.

Control

Intervention Type BEHAVIORAL

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.

Arm C

Subjects will receive in-person education alone AND subjects will receive control intervention

Group Type EXPERIMENTAL

In-person education

Intervention Type BEHAVIORAL

Four in-person hands-on nutrition and physical activity education classes and cooking sessions.

Control

Intervention Type BEHAVIORAL

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.

Arm D

Subjects will receive control intervention

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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In-person education

Four in-person hands-on nutrition and physical activity education classes and cooking sessions.

Intervention Type BEHAVIORAL

E-communication

11 months of motivational text messages, emailed newsletters, and access to a website.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Female.
2. 21 years of age or older.
3. Self-identify as Hispanic/Latina.
4. Speak Spanish or English.

Disease Related Criteria
5. Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease.

Prior/ Current Therapy Criteria
6. 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
7. Have access to computer or smartphone.

Clinical/ Laboratory Criteria
8. No history of smoking within the past 30 days.
9. No uncontrolled diabetes mellitus defined as Hgb A1C \>7%
10. Consume \<5 servings of fruits and vegetables per day and/or engages in \<150 weekly minutes of moderate to vigorous physical activity.