Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

Columbia University

Status: Completed

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02780271

R01CA186080 (U.S. NIH Grant/Contract)

AAAP0461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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230 participants in 4 patient groups

Arm A

Experimental group

Description:

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

Treatment:

Behavioral: E-communication

Behavioral: Control

Behavioral: In-person education

Arm B

Experimental group

Description:

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

Treatment:

Behavioral: E-communication

Behavioral: Control

Arm C

Experimental group

Description:

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

Treatment:

Behavioral: Control

Behavioral: In-person education

Arm D

Active Comparator group

Description:

Subjects will receive control intervention

Treatment:

Behavioral: Control