Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: In-person education; Behavioral: E-communication; Behavioral: Control

• Registration Number: NCT02780271
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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.

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Exclusion Criteria

Any criterion not met under inclusion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arm A	Control	Subjects will receive in-person education plus e-communication AND subjects will receive control intervention
Arm B	Control	Subjects will receive e-communication alone AND subjects will receive control intervention
Arm C	Control	Subjects will receive in-person education alone AND subjects will receive control intervention
Arm A	In-person education	Subjects will receive in-person education plus e-communication AND subjects will receive control intervention
Arm D	Control	Subjects will receive control intervention
Arm A	E-communication	Subjects will receive in-person education plus e-communication AND subjects will receive control intervention
Arm B	E-communication	Subjects will receive e-communication alone AND subjects will receive control intervention
Arm C	In-person education	Subjects will receive in-person education alone AND subjects will receive control intervention

Primary Outcome Measures

Name	Time	Method
Change in daily servings of fruit/vegetables	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.
Change in energy density	Baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Physical Activity	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States