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Risk Communication Within Mexican-American Families
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), December 2008
First Received: May 3, 2007   Last Updated: August 24, 2009   History of Changes
Sponsored by: National Human Genome Research Institute (NHGRI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00469339
  Purpose

This study will examine what methods work best for encouraging Mexican-American family members to talk about their risk for diabetes, heart disease, breast cancer and colon cancer. Within the Mexican-American community, the family culture provides an important setting in which individuals interpret and share their health information and formulate strategies to engage in health-promoting behaviors. The information from the study will be used to design risk communication approaches for Mexican-American households.

Members of households with at least three adults 18 to 70 years of age who are part of the existing Mexican-American households recruited by the University of Texas M.D. Anderson Cancer Center may be eligible for this study.

Participants are interviewed about their medical history, family history of disease, health behaviors, beliefs about disease and disease risk, experiences living in the United States, and relationships with family members and close friends. They are then provided information about their family risk for diabetes, heart disease, breast cancer and colon cancer, based on the information they provided in the interview. Two additional interviews are conducted over the telephone that include questions about how the participants communicate with family members about their risk and health behaviors.


Condition Intervention
Diabetes
Colon Cancer
Cardiovascular Disease
Behavioral: Family Health History

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Historical Control, Factorial Assignment, Efficacy Study
Official Title: The Role of Family History and Culture in Communal Coping Within Mexican-American Families

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Family Communication about Risk

Secondary Outcome Measures:
  • Illness representations, Cooperative strategies to screen and adopt healthy behaviors

Estimated Enrollment: 560
Study Start Date: April 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Family Health History
    N/A
Detailed Description:

The current project aims to understand the mechanisms underlying communications about familial risk for common, complex diseases and the development of strategies by Mexican American families to address this risk. For the Mexican American community, the family culture provides an important setting within which individuals will interpret their health information, share health information, and formulate strategies to engage in health promoting behaviors. This family culture can be defined by the family social structure, the degree of acculturation represented by household members, as well as socio-economic factors. Participants for the current project will be recruited from an ongoing population-based cohort of Mexican American households initiated by the Department of Epidemiology at the University of Texas MD Anderson Cancer Center (UTMDACC). At least three adults, two of which are biological relatives, living within the same residence from 160 multigenerational Mexican American households will participate in this study. Medical risk information (feedback) will be provided to participants based upon family history information that they provide about four complex diseases: diabetes, heart disease, breast cancer and colon cancer. The feedback will be randomized in two ways, varying who within the family is provided the feedback (Receiver of the Feedback) and what information is provided (Content of Feedback). The data will allow us to examine whether the family-centered feedback approach (where all participating family members receive feedback), rather than the individual-focused feedback approach (where only one participating family member receives feedback), encourages communications regarding disease risk among family members. The medical risk feedback will also be randomized as to whether they receive disease risk information only (predisposing risk feedback) or disease risk information coupled with personalized recommendations for behavior change to reduce risks (predisposing plus enabling feedback). These data will allow us to examine the impact of the content of risk feedback based on the CDC's family health history tool Family Healthware[Trademark] on beliefs concerning the underlying causes and controllability of common diseases. Cross comparisons between the data obtained from who receives the medical risk information and the content of that information will help in understanding the role of beliefs about disease and communication about family risk for disease in the development of shared perceptions of risk and strategies to adopt health promoting behaviors within the family.

The role of the familial and cultural context in the communication and strategy development process will also be investigated.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA

Member household of existing population-based cohort of Mexican-American households recruited by the Department of Epidemiology at UTMDACC. The existing population-based cohort consists of self-identified Mexican-Americans living in predominantly Mexican-American neighborhoods in the Houston area. All individuals in the cohort are 18 years of age or older and had to be able to complete a personal interview.

Household includes at least three adults (18 to 70 years of age) who are willing to participate in the study, where at least two of the household participants are related biologically and represent differing generations, and additionally in which one household participant is a spouse or partner of another household participant.

Ability for each participating household member to complete one in-home survey instrument via computerized assessment tool or personal interview and to complete two telephone interviews.

Ability of all household participants to speak either English or Spanish.

EXCLUSION CRITERIA

More than two household members are unable to complete the baseline questionnaire using a computerized assessment tool.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469339

Contacts
Contact: Laura M. Koehly, Ph.D. (301) 451-3999 koehlyl@mail.nih.gov

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999907140, 07-HG-N140
Study First Received: May 3, 2007
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00469339     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diabetes
Colon Cancer
Cardiovascular Disease

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Diabetes Mellitus
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Cardiovascular Diseases
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009