Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

NCT02780271 | Completed DMC

• 2 other identifiers: AAAP0461R01CA186080
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Physical Activity

  Baseline, 6 months, 12 months

Study Arms (4)

Arm A

EXPERIMENTAL

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

Behavioral: In-person education; Behavioral: E-communication; Behavioral: Control

Arm B

EXPERIMENTAL

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

Behavioral: E-communication; Behavioral: Control

Arm C

EXPERIMENTAL

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

Behavioral: In-person education; Behavioral: Control

Arm D

ACTIVE COMPARATOR

Subjects will receive control intervention

Behavioral: Control

Interventions

In-person education BEHAVIORAL

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

Arm A; Arm C

E-communication BEHAVIORAL

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

Arm A; Arm B

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.

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 34709529 DERIVED

• 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.

  PMID: 34365016 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Dawn Hershman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: February 1, 2016
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

US (1)