Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780271
• Other study ID #: AAAP0461
• Secondary ID: R01CA186080
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: September 11, 2020

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Exclusion Criteria:

Any criterion not met under inclusion.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• In-person education
Four in-person hands-on nutrition and physical activity education classes and cooking sessions.
• E-communication
11 months of motivational text messages, emailed newsletters, and access to a website.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in energy density		Baseline, 6 months, 12 months
Secondary	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