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Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

In-person education

E-communication

Control

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Cancer survivor, e-communication, diet and physical activity, fruits/vegetables daily servings, energy density

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm C

Arm D

Arm Description

Subjects will receive in-person education plus e-communication AND subjects will receive control intervention

Subjects will receive e-communication alone AND subjects will receive control intervention

Subjects will receive in-person education alone AND subjects will receive control intervention

Subjects will receive control intervention

Outcomes

Primary Outcome Measures

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.

Change in energy density

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02780271

First Posted

May 19, 2016

Last Updated

July 13, 2021

Sponsor

Columbia University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02780271

Brief Title

Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

September 11, 2020 (Actual)

Study Completion Date

September 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Cancer survivor, e-communication, diet and physical activity, fruits/vegetables daily servings, energy density

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Subjects will receive in-person education plus e-communication AND subjects will receive control intervention

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Subjects will receive e-communication alone AND subjects will receive control intervention

Arm Title

Arm C

Arm Type

Experimental

Arm Description

Subjects will receive in-person education alone AND subjects will receive control intervention

Arm Title

Arm D

Arm Type

Active Comparator

Arm Description

Subjects will receive control intervention

Intervention Type

Behavioral

Intervention Name(s)

In-person education

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

E-communication

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

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 Outcome Measure Information:

Title

Change in daily servings of fruit/vegetables

Description

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

Time Frame

Baseline, 6 months, 12 months

Title

Change in energy density

Time Frame

Baseline, 6 months, 12 months

Secondary Outcome Measure Information:

Title

Change in Physical Activity

Description

Time Frame

Baseline, 6 months, 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dawn Hershman, MD, MS

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34709529

Citation

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.

Results Reference

derived

PubMed Identifier

34365016

Citation

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.

Results Reference

derived

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Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

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