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OpenTrials
Completed

NCT Number: NCT02780271

Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

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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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-person education

Behavioral

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

E-communication

Behavioral

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

Control

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.

Primary outcomes

  1. Change in daily servings of fruit/vegetables

    Time frame: Baseline, 6 months, 12 months

    Self-reported habitual fruit and vegetable intake will be assessed using the 10-item National Cancer Institute (NCI) All-Day Fruit and Vegetable screener.

  2. Change in energy density

    Time frame: Baseline, 6 months, 12 months

Secondary outcomes

  1. Change in Physical Activity

    Time frame: Baseline, 6 months, 12 months

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 23, 2016
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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