Breast Cancer Clinical Trial

Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Summary

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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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

230

Study ID:

NCT02780271

Recruitment Status:

Completed

Sponsor:

Columbia University

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There is 1 Location for this study

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Columbia University Irving Medical Center
New York New York, 10032, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

230

Study ID:

NCT02780271

Recruitment Status:

Completed

Sponsor:


Columbia University

How clear is this clinincal trial information?

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