Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA186080 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Subjects will receive in-person education plus e-communication AND subjects will receive control intervention |
|
| Arm B | Experimental | Subjects will receive e-communication alone AND subjects will receive control intervention |
|
| Arm C | Experimental | Subjects will receive in-person education alone AND subjects will receive control intervention |
|
| Arm D | Active Comparator | Subjects will receive control intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-person education | Behavioral | Four in-person hands-on nutrition and physical activity education classes and cooking sessions. |
|
| 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 |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dawn Hershman, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34709529 | Derived | 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. | |
| 34365016 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| E-communication | Behavioral | 11 months of motivational text messages, emailed newsletters, and access to a website. |
|
| 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. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |