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Diet and Physical Activity Changes Among Latina Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02780271
Recruitment Status : Unknown
Verified May 2016 by Heather Greenlee, Columbia University.
Recruitment status was:  Recruiting
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Heather Greenlee, Columbia University

Brief Summary:
We 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: In-person education Behavioral: E-communication Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mi Vida Saludable: Maintaining Diet and Physical Activity Changes Among Latina Breast Cancer Survivors
Study Start Date : February 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Arm A
Subjects will receive in-person education plus e-communication AND subjects will receive control intervention
Behavioral: In-person education
Four in-person hands-on nutrition and physical activity education classes and cooking sessions.

Behavioral: E-communication
11 months of motivational text messages, emailed newsletters, and access to a website.

Behavioral: Control
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.

Experimental: Arm B
Subjects will receive e-communication alone AND subjects will receive control intervention
Behavioral: E-communication
11 months of motivational text messages, emailed newsletters, and access to a website.

Behavioral: Control
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.

Experimental: Arm C
Subjects will receive in-person education alone AND subjects will receive control intervention
Behavioral: In-person education
Four in-person hands-on nutrition and physical activity education classes and cooking sessions.

Behavioral: Control
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.

Active Comparator: Arm D
Subjects will receive control intervention
Behavioral: Control
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 Measures :
  1. Change in daily servings of fruit/vegetables [ Time Frame: Baseline, 6 months, 12 months ]
  2. Change in energy density [ Time Frame: Baseline, 6 months, 12 months ]

Secondary Outcome Measures :
  1. Change in physical activity [ Time Frame: Baseline, 6 months, 12 months ]
    Questionnaire (IPAQ).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780271


Contacts
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Contact: Heather Greenlee, ND, PhD 212-342-4130 hg2120@columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Heather Greenlee, ND, PhD    212-342-4130    hg2120@columbia.edu   
Principal Investigator: Heather Greenlee, ND, PhD         
Sponsors and Collaborators
Columbia University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heather Greenlee, ND, PhD Columbia University
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Responsible Party: Heather Greenlee, Assistant Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02780271    
Other Study ID Numbers: AAAP0461
R01CA186080 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Heather Greenlee, Columbia University:
Breast Cancer
Cancer survivor
e-communication
diet and physical activity
fruits/vegetables daily servings
energy density
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases