Colon CancerNCT02767986
Where Culture Meets Genetics: Exploring Latinas Causal Attributions of Breast and Colon Cancer and Models of Disease Inheritance
An observational study of Colon Cancer and Breast Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Colon Cancer, Breast Cancer
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to 2 Feb 2017
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who speak spanish as their primary language; living in the metropolitan Baltimore/Washington, DC region
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- -NIH medical and research staff
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: Where Culture Meets Genetics: Exploring Latinas' Causal Attributions of Breast and Colon Cancer and Mental Models of Disease Inheritance
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.
Read more
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
...
Read the 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 and from among individuals enrolled on other NIH Clinical Center protocols. 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 open-ended questions.
- Conditions
- Colon Cancer, Breast Cancer
- Keywords
- Cultural Consensus, Natural History
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spanish-speaking Latinas | Women who speak Spanish as their primary language |
What is being measured
The primary outcome is the main question the study is designed to answer.
mental models of inheritance
qualitative descriptions of women's understanding/thoughts about inheritance
Measured: baseline
causal attributions of colon cancer
participants' free-lists of colon cancer causes
Measured: baseline
causal attributions of breast cancer
participants' free-lists of breast cancer causes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start10 May 2016
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori Erby, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767986
- Sponsor's protocol ID
- 999916106
- Other IDs
- 16-HG-N106
- Status last verified
- Aug 2024
- First submitted
- 10 May 2016
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Where Culture Meets Genetics: Exploring Latinas' Causal Attributions of Breast and Colon Cancer and Mental Models of Disease Inheritance
- ClinicalTrials.gov ID
- NCT02767986
- Acronym / sponsor ID
- 999916106
- Conditions
- Colon Cancer, Breast Cancer
- Keywords
- Cultural Consensus, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 10 May 2016 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 11 May 2016 (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.
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 and from among individuals enrolled on other NIH Clinical Center protocols. 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 open-ended questions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish-speaking Latinas | – | –Women who speak Spanish as their primary language |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who speak spanish as their primary language; living in the metropolitan Baltimore/Washington, DC region
Key inclusion criteria (9 listed)
- 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
- Eres mujer y tienes 18 a(SqrRoot) os de edad o m(SqrRoot)(Degree)s
Key exclusion criteria (1 listed)
- -NIH medical and research staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mental models of inheritance
Time frame: baseline
qualitative descriptions of women's understanding/thoughts about inheritance
causal attributions of colon cancer
Time frame: baseline
participants' free-lists of colon cancer causes
causal attributions of breast cancer
Time frame: baseline
participants' free-lists of breast cancer causes
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Lori Erby, 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 Colon Cancer and Breast Cancer, 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 9 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 3 Sep 2024. 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?
mental models of inheritance (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2024.