Breast CarcinomaNCT06112795
Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County
An observational study of Breast Carcinoma and Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This study explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma, Breast Cancer, Breast Cancer Female
- What is being tested?
- Non-Interventional Study
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 3 May 2023
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Under and uninsured Hispanic women living in Maricopa county
Who may be able to join
- AIM 1:
- Completed a baseline survey for the Latinas Learning about Density (LLEAD) study
- Self-identify as Hispanic
- Between 40-65 years of age
- AIM 2:
- Between the ages of 45 and 65
Show all 10Show fewer
- Self-identify as Hispanic
- Current residence in Maricopa County
- Be under- (e.g. Arizona Health Care Cost Containment System) or uninsured at the time of enrollment
- Can read and speak English or Spanish well enough to understand and complete the informed consent process and take part in either a focus group or individual interview
Who cannot join
- AIM I:
- Women with a history of breast cancer
- AIM 2:
- Women with a history of breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
This study explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the association between perceived risk and mammography screening behavior and differences in perceived risk by patient characteristics in Hispanic women screened at Mountain Park Health Center (MPHC).
II. Characterize attitudes, beliefs, and barriers towards mammography screening and cultural acceptability of BRCA models in community settings using focus group and interview data from under- and uninsured Hispanic women in Maricopa County.
OUTLINE: This is an observational study.
Participants attend an interview or participate in a focus group on study.
- Conditions
- Breast Carcinoma, Breast Cancer, Breast Cancer Female
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants attend an interview or participate in a focus group on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography screening behavior
Mammography screening behavior will be measured using two self-reported items: 1) history of ever having a mammogram, with a yes/no response and 2) history of last (most recent) mammogram" with the following response options: within the past year; at least 1, but less than 2 years ago; at least 2, but less than 5 years ago; 5 or more years ago; don't remember. Using these two items, a new variable of mammography screening behavior will be created, defined as the number of prior mammograms, categorizing responses as 0, 1 to 2, and 2+.
Measured: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start10 Nov 2022
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica D. Austin, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112795
- Sponsor's protocol ID
- 22-001884
- Other IDs
- NCI-2023-00465, 22-001884
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Cultural Acceptability of Community Breast Cancer Risk Assessment Among Hispanic Women in Maricopa County
- ClinicalTrials.gov ID
- NCT06112795
- Acronym / sponsor ID
- 22-001884
- Conditions
- Breast Carcinoma, Breast Cancer, Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 1 Nov 2023 (actual)
- 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 explores the cultural acceptability of community breast cancer risk assessment among Hispanic women in Maricopa county.
Detailed description
PRIMARY OBJECTIVES:
- Examine the association between perceived risk and mammography screening behavior and differences in perceived risk by patient characteristics in Hispanic women screened at Mountain Park Health Center (MPHC).
II. Characterize attitudes, beliefs, and barriers towards mammography screening and cultural acceptability of BRCA models in community settings using focus group and interview data from under- and uninsured Hispanic women in Maricopa County.
OUTLINE: This is an observational study.
Participants attend an interview or participate in a focus group on study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants attend an interview or participate in a focus group on study. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Under and uninsured Hispanic women living in Maricopa county
Key inclusion criteria (10 listed)
- AIM 1:
- AIM 2:
Key exclusion criteria (4 listed)
- AIM I:
- AIM 2:
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Mammography screening behavior
Time frame: Baseline (at enrollment)
Mammography screening behavior will be measured using two self-reported items: 1) history of ever having a mammogram, with a yes/no response and 2) history of last (most recent) mammogram" with the following response options: within the past year; at least 1, but less than 2 years ago; at least 2, but less than 5 years ago; 5 or more years ago; don't remember. Using these two items, a new variable of mammography screening behavior will be created, defined as the number of prior mammograms, categorizing responses as 0, 1 to 2, and 2+.
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 7 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jessica D. Austin, Ph.D. principal investigator
Mayo Clinic
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 Carcinoma and Breast Cancer, run by Mayo Clinic 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 10 inclusion and 4 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 7 Feb 2025. 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?
Mammography screening behavior (time frame: Baseline (at enrollment)). 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 7 Feb 2025.