Clinical trial NCT02780271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Cancer survivor
e-communication
diet and physical activity
fruits/vegetables daily servings
energy density
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-05-23
Enrollment: 230
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in daily servings of fruit/vegetables
timeFrame: Baseline, 6 months, 12 months
measure: Change in energy density
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.