Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Mi Vida Saludable: Maintaining 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: In-person education; Behavioral: E-communication; Behavioral: 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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Subjects will receive in-person education plus e-communication AND subjects will receive control intervention	Behavioral: In-person education; Four in-person hands-on nutrition and physical activity education classes and cooking sessions.; Behavioral: E-communication; 11 months of motivational text messages, emailed newsletters, and access to a website.; 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.
Experimental: Arm B; Subjects will receive e-communication alone AND subjects will receive control intervention	Behavioral: E-communication; 11 months of motivational text messages, emailed newsletters, and access to a website.; 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.
Experimental: Arm C; Subjects will receive in-person education alone AND subjects will receive control intervention	Behavioral: In-person education; Four in-person hands-on nutrition and physical activity education classes and cooking sessions.; 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.
Active Comparator: Arm D; Subjects will receive control intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in energy density		Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dawn Hershman, MD, MS, Columbia University

Publications and helpful links

General Publications

• Marin-Chollom AM, Hale C, Koch P, Gaffney AO, Contento I, Shen H, Hershman DL, Brickman AM, Greenlee H. Cognitive Functioning and Health in Hispanic/Latina Breast Cancer Survivors. J Immigr Minor Health. 2022 Jun;24(3):597-604. doi: 10.1007/s10903-021-01300-w. Epub 2021 Oct 28.
• Santiago-Torres M, Contento I, Koch P, Tsai WY, Brickman AM, Gaffney AO, Thomson CA, Crane TE, Dominguez N, Sepulveda J, Marin-Chollom AM, Paul R, Shi Z, Ulanday KT, Hale C, Hershman D, Greenlee H. inverted exclamation markMi Vida Saludable! A randomized, controlled, 2 x 2 factorial trial of a diet and physical activity intervention among Latina breast cancer survivors: Study design and methods. Contemp Clin Trials. 2021 Nov;110:106524. doi: 10.1016/j.cct.2021.106524. Epub 2021 Aug 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer survivor; e-communication; diet and physical activity; fruits/vegetables daily servings; energy density
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: AAAP0461; R01CA186080 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No