Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Where Culture Meets Genetics: Exploring Latinas Causal Attributions of Breast and Colon Cancer and Models of Disease Inheritance

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: NCT02767986
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date May 10, 2016
First Posted Date May 11, 2016
Last Update Posted Date January 14, 2019
Study Start Date May 10, 2016
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 5, 2019)
  • casual attributions of breast cancer [ Time Frame: baseline ]
    participants' free lists of breast cancer causes
  • causal attributions of breast cancer [ Time Frame: baseline ]
    participants' free lists of colon cancer causes
  • mental modes of inheritance [ Time Frame: baseline ]
    qualitative descriptions of women's understanding/thoughts about inheritance
Original Primary Outcome Measures
 (submitted: May 10, 2016)
Participant's responses to qualitative interview questions [ Time Frame: Study Completion ]
Change History Complete list of historical versions of study NCT02767986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Where Culture Meets Genetics: Exploring Latinas Causal Attributions of Breast and Colon Cancer and Models of Disease Inheritance
Official Title Where Culture Meets Genetics: Exploring Latinas' Causal Attributions of Breast and Colon Cancer and Mental Models of Disease Inheritance
Brief Summary

Background:

Culture can affect the way a person thinks about illness. This can affect how they seek help for illness. It can also affect how they choose a treatment and follow it. This can lead to health disparities among certain groups of people. Breast and colon cancers are the most common cancers for Latinos. Even though they get these cancers at lower rates than other population groups, Latinos are more likely to be diagnosed with these cancers at advanced stages. Researchers want to study what Latina women immigrants believe causes breast and colon cancer and other factors they think play a role in disease. This understanding could lead to better interactions between Latinos and their doctors.

Objective:

To learn more about what Latina immigrants believe causes breast and colon cancer and other factors they think play a role in disease.

Eligibility:

Women ages 18 and older who:

Were born in Latin America

Speak Spanish

Have never had breast, ovarian, or colon cancer

Design:

Participants will be interviewed in person or over the phone. This will take up to an hour. The interview will be recorded. Participants will answer questions about:

Their family s cancer history

What they think causes breast and colon cancer

What they think plays a role in disease

Detailed Description

Research to understand the sources of health disparities has acknowledged that in addition to biomedical risk factors, culture plays an important role in differential health outcomes. Consequently, understanding cultural differences that may influence health behavior is key in working towards reducing these disparities. Causal attributions are a key component of individuals illness perceptions and thus impact health behaviors, which may present as health disparities at a population level. While research has explored non-Hispanic White women s causal attributions of breast cancer, less is known about Latina s beliefs about the causes of breast cancer, and little is known about causal attributions of colon cancer in any population. Understanding Latina s causal attributions of breast and colon cancer may provide insight into the determinants of cancer disparities in this population. Because a subset of both breast and colon cancers result from single gene mutations, which confer an increased risk of developing such cancers, understanding causal attributions in Latina populations is relevant to the field of genetics. This is especially true since Latinas have historically underutilized cancer genetic risk assessment counseling and testing services. As these services become a standard part of general healthcare provision, it will become increasingly important to understand ways in which different cultural groups interact with genetic information. One way this can be done is through investigating culturally informed mental models of disease risk and inheritance. This study seeks to describe causal attributions of breast and colon cancer and to explore mental models of disease inheritance among Latina immigrants. A qualitative exploratory design including interviews comprised of free-listing, ranking, and open-ended questions will be used. Participants will be recruited through the NIH Clinical Research Volunteer Program as well as using other resources within the Office of Participant Recruitment. First, we will describe Latina s causal attributions for these cancers. Next, we will use cultural consensus theory (CCT) to identify and describe common cultural models of causes of these cancers. Finally, we will explore Latina s mental models of disease inheritance using both free-listing and openended questions.

2. Objectives and specific aims.

The objective of this study is to describe the cultural models of Latina immigrants regarding causal attributions of breast and colon cancer as well as to explore this group s mental models of disease inheritance.

Aim #1: To identify the main causal attributions of breast and colon cancers among Latina immigrants.

Aim #2: To use cultural consensus analysis to identify the presence or absence of shared cultural models of causal attributions for breast and colon cancers among participants.

Aim #3: To describe the mental models of disease inheritance held by members of the Latina immigrant population.

3. Brief Rationale and Background:

Latinos in the United States

Hispanic or Latino is currently the largest minority group in the United States, constituting 17% of the population as of 2013 according to the U.S. Census Bureau. In Maryland specifically, the 2010 census found 8.3% of the population to be Hispanic or Latino, and as of July 2014, the U.S. Census Bureau estimates that 9.2% of the Maryland population is Hispanic or Latino. Notably, the absolute number of Hispanics or Latinos in Maryland doubled during the period 2000-2010, indicating the high level of growth in this segment of the population (http://quickfacts.census.gov/qfd/states/24000lk.html). The U.S. Office of Management and Budget (OMB) defines Hispanic or Latino as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin regardless of race (http://www.census.gov/topics/population/hispanic-origin/about.html). For the purposes of this proposal, the terms Latino/a will refer to people of Spanish-speaking countries of the Western hemisphere, and Latino/a immigrants will refer to persons born in one of these countries who have since immigrated to the United States. Notably, this working definition excludes people of Spanish or Brazilian nationality or descent, mainly due to the cultural focus of this investigation.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women who speak spanish as their primary language; living in the metropolitan Baltimore/Washington, DC region
Condition
  • Colon Cancer
  • Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Spanish-speaking Latinas
Women who speak Spanish as their primary language
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
22
Original Estimated Enrollment
 (submitted: May 10, 2016)
75
Actual Study Completion Date February 2, 2017
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:
  • Are a woman, 18 years of age or older
  • Have immigrated to the United States from Latin America
  • Speak Spanish
  • Are able to meet in-person in the metro Washington, DC area

Puedes reunir los requisitos si:

  • Eres mujer y tienes 18 a(SqrRoot) os de edad o m(SqrRoot)(Degree)s
  • Has emigrado a los Estados Unidos desde Latinoam(SqrRoot)(Copyright)rica
  • Hablas el espa(SqrRoot) ol con fluidez
  • Puedes asistir en persona en la zona metropolitana de Washington, DC

EXCLUSION CRITERIA:

-NIH medical and research staff

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02767986
Other Study ID Numbers 999916106
16-HG-N106
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Lori Erby, Ph.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 4, 2019