Breast CancerNCT00469339
Risk Communication Within Mexican-American Families
An observational study of Breast Cancer and Diabetes, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Diabetes, Colon Cancer
- What is being tested?
- Family Health History
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mexican-American households@@@
Who may be able to join
- 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.
Who cannot join
- More than two household members are unable to complete the baseline questionnaire using a computerized assessment tool.
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030-4096
About this study
Official title: The Role of Family History and Culture in Communal Coping Within Mexican American Families
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.
Read the 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 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.
- Conditions
- Breast Cancer, Diabetes, Colon Cancer, Cardiovascular Disease
- Being tested
- Family Health History
- Keywords
- Breast Cancer, Diabetes, Colon Cancer, Cardiovascular Disease, Natural History
- Medical subject headings
- Breast Neoplasms, Diabetes Mellitus, Colonic Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Health HistoryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| cohort of Mexican-American households | cohort of Mexican-American households Receives: Behavioral: Family Health History |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understand how culture and the familial social system facilitate or impede communications regarding family health history and risk for disease, and the development of strategies to adopt health promoting behaviors.
Understand how culture and the familial social system facilitate or impede communications regarding family health history and risk for disease, and the development of strategies to adopt health promoting behaviors.
Measured: one survey and two telephone interviews
Investigate whether the type of personalized risk feedback (predisposing or predisposing plus enabling) affects family members beliefs about the causes and controllability of disease onset and perceived risk for disease.
Investigate whether the type of personalized risk feedback (predisposing or predisposing plus enabling) affects family members beliefs about the causes and controllability of disease onset and perceived risk for disease.
Measured: one survey and two telephone interviews
Investigate whether shared perceptions of risk and beliefs about disease mediates the relationship between communications about family risk and the development of cooperative strategies to adopt health promoting behaviors within the family.
Investigate whether shared perceptions of risk and beliefs about disease mediates the relationship between communications about family risk and the development of cooperative strategies to adopt health promoting behaviors within the family.
Measured: one survey and two telephone interviews
Examine whether a family-centered feedback approach, as compared to an individual-focused approach, encourages communications regarding family risk and the development of strategies to adopt health promoting behaviors within the household.
Examine whether a family-centered feedback approach, as compared to an individual-focused approach, encourages communications regarding family risk and the development of strategies to adopt health promoting behaviors within the household.
Measured: one survey and two telephone interviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study start27 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Laura M Koehly, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469339
- Sponsor's protocol ID
- 999907140
- Other IDs
- 07-HG-N140
- Status last verified
- 9 Jun 2026
- First submitted
- 3 May 2007
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glass TA, McAtee MJ. Behavioral science at the crossroads in public health: extending horizons, envisioning the future. Soc Sci Med. 2006 Apr;62(7):1650-71. doi: 10.1016/j.socscimed.2005.08.044. Epub 2005 Sep 29.
PubMed 16198467Green LW. Public health asks of systems science: to advance our evidence-based practice, can you help us get more practice-based evidence? Am J Public Health. 2006 Mar;96(3):406-9. doi: 10.2105/AJPH.2005.066035. Epub 2006 Jan 31.
PubMed 16449580Susser M. The tribulations of trials--intervention in communities. Am J Public Health. 1995 Feb;85(2):156-8. doi: 10.2105/ajph.85.2.156. No abstract available.
PubMed 7856769Lin J, Marcum CS, Wilkinson AV, Koehly LM. Developing Shared Appraisals of Diabetes Risk Through Family Health History Feedback: The Case of Mexican-Heritage Families. Ann Behav Med. 2018 Feb 17;52(3):262-271. doi: 10.1093/abm/kax037.
PubMed 29538667
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Family History and Culture in Communal Coping Within Mexican American Families
- ClinicalTrials.gov ID
- NCT00469339
- Acronym / sponsor ID
- 999907140
- Conditions
- Breast Cancer, Diabetes, Colon Cancer, Cardiovascular Disease
- Keywords
- Breast Cancer, Diabetes, Colon Cancer, Cardiovascular Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 27 Apr 2007
- First posted
- 4 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort of Mexican-American households | – | Behavioral: Family Health Historycohort of Mexican-American households |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mexican-American households@@@
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- More than two household members are unable to complete the baseline questionnaire using a computerized assessment tool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Health History | Behavioural | cohort of Mexican-American households |
Primary outcome
Understand how culture and the familial social system facilitate or impede communications regarding family health history and risk for disease, and the development of strategies to adopt health promoting behaviors.
Time frame: one survey and two telephone interviews
Understand how culture and the familial social system facilitate or impede communications regarding family health history and risk for disease, and the development of strategies to adopt health promoting behaviors.
Investigate whether the type of personalized risk feedback (predisposing or predisposing plus enabling) affects family members beliefs about the causes and controllability of disease onset and perceived risk for disease.
Time frame: one survey and two telephone interviews
Investigate whether the type of personalized risk feedback (predisposing or predisposing plus enabling) affects family members beliefs about the causes and controllability of disease onset and perceived risk for disease.
Investigate whether shared perceptions of risk and beliefs about disease mediates the relationship between communications about family risk and the development of cooperative strategies to adopt health promoting behaviors within the family.
Time frame: one survey and two telephone interviews
Investigate whether shared perceptions of risk and beliefs about disease mediates the relationship between communications about family risk and the development of cooperative strategies to adopt health promoting behaviors within the family.
Examine whether a family-centered feedback approach, as compared to an individual-focused approach, encourages communications regarding family risk and the development of strategies to adopt health promoting behaviors within the household.
Time frame: one survey and two telephone interviews
Examine whether a family-centered feedback approach, as compared to an individual-focused approach, encourages communications regarding family risk and the development of strategies to adopt health promoting behaviors within the household.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 16198467Glass TA, McAtee MJ. Behavioral science at the crossroads in public health: extending horizons, envisioning the future. Soc Sci Med. 2006 Apr;62(7):1650-71. doi: 10.1016/j.socscimed.2005.08.044. Epub 2005 Sep 29.
- Background: PubMed 16449580Green LW. Public health asks of systems science: to advance our evidence-based practice, can you help us get more practice-based evidence? Am J Public Health. 2006 Mar;96(3):406-9. doi: 10.2105/AJPH.2005.066035. Epub 2006 Jan 31.
- Background: PubMed 7856769Susser M. The tribulations of trials--intervention in communities. Am J Public Health. 1995 Feb;85(2):156-8. doi: 10.2105/ajph.85.2.156. No abstract available.
- Derived from this study: PubMed 29538667Lin J, Marcum CS, Wilkinson AV, Koehly LM. Developing Shared Appraisals of Diabetes Risk Through Family Health History Feedback: The Case of Mexican-Heritage Families. Ann Behav Med. 2018 Feb 17;52(3):262-271. doi: 10.1093/abm/kax037.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Koehly, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Diabetes, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understand how culture and the familial social system facilitate or impede communications regarding family health history and risk for disease, and the development of strategies to adopt health promoting behaviors. (time frame: one survey and two telephone interviews). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00469339, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.