Breast CancerNCT02205736

Breast Health Education for Underserved Latino Women

A study testing Breast Health Education in people with Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Breast Health Education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 329 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Latino
Female
At least 18 years old
Resident of Union County or Mecklenburg County, North Carolina

Who cannot join

Non-Latino
Male
Less than 18 years old
Not a resident of Union County or Mecklenburg County, North Carolina

Trial locations and contacts

1 site in 1 country.

United States1 site

Levine Cancer Institute
Charlotte, North Carolina, 28204

Other trials in United States

About this study

Official title: A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County

Subjects will be recruited from the participants in the Union and Mecklenburg County Living Room Visits. Participants in the Living Room Visit will have been recruited using community event flyers. During the Living Room Visits, the Health Educator will provide a general overview of the study. Individuals who are interested in participating in the study will then be generally screened for eligibility by the Protocol Coordinator who will then proceed to provide informed consent to potential subjects.

Read the detailed description

In an effort to increase early detection of breast cancer our program is designed to remove some of the most common barriers faced by uninsured Latino women including lack of breast health knowledge and inability to pay for screening. The Levine Cancer Institute offers breast cancer education and screening in the growing Latino populations of both Mecklenburg and Union Counties through educational programs known as "Living Room Visits." Living Room Visits are educational sessions hosted at a participant's house that will be led by a Carolinas Healthcare System (CHS) certified bilingual health educator. At least 250 women will participant in the educational sessions between both counties with each session hosting 12-15 participants. Of those women participating in Living Room Visits, those interested will be individually informed of the research opportunity and provided informed consent before being asked to take a pre-test survey. After the educational session, subjects who consented to the study will also complete a post-test survey. Three months after each Living Room Visit, subjects will also be called to complete another post-test survey to assess educational retention. Phone calls and post-test surveys will be administered by Collaborative Institutional Training Initiative (CITI) trained CHS certified bilingual employees only. Analysis of the pre and post-intervention surveys will be administered by a CHS statistician using de-identified data.

Conditions: Breast Cancer
Being tested: Breast Health Education
Keywords: Breast health education, Latino women, Group education, Breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breast Health EducationOther
Small group breast health educational sessions for Latino women in home setting.

Study groups in NCT02205736
Study group	Role	What they receive
Living Room Visit participants	Other	Latino women who received breast health education while attending a Living Room Visit. Receives: Other: Breast Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention).
Participants completed 25-item questionnaires requiring True/False responses to evaluate breast health knowledge at Baseline and Post-Intervention. True/False responses were recoded as being correct or incorrect, resulting in 25 unique 2x2 contingency tables of paired, dichotomous survey responses. Reported here are the frequencies of paired subject responses for each question on the Baseline and Post-Intervention questionnaires.
Questions are listed below as Row Titles.
Abbreviations to note include:
Question: Q Mammography, Mammogram: MAM Breast cancer: BC True/False: T/F
Measured: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.

Secondary outcomes (1)

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Three Months After the Intervention to Assess Retention (i.e., 3-Month Contact)
Participants completed 25-item questionnaires requiring True/False responses to evaluate breast health knowledge at Baseline and 3-Month Contact. True/False responses were recoded as being correct or incorrect, resulting in 25 unique 2x2 contingency tables of paired, dichotomous survey responses. Reported here are the frequencies of paired subject responses for each question on the Baseline and 3-Month Contact questionnaires.
Questions are listed below as Row Titles.
Abbreviations to note include:
Question: Q Mammography, Mammogram: MAM Breast cancer: BC True/False: T/F
Measured: Baseline to 3-Month Contact; duration is approximately three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Nov 2016

First posted31 Jul 2014 (estimated)
Study startJul 2014
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02205736
Sponsor's protocol ID: LCI-BRE-NOS-HEP-001
Status last verified: Apr 2024
First submitted: 29 Jul 2014
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Cross Sectional Study of a Breast Health Education Program for Under-served Latino Women in Union and Mecklenburg County
ClinicalTrials.gov ID: NCT02205736
Acronym / sponsor ID: LCI-BRE-NOS-HEP-001
Conditions: Breast Cancer
Keywords: Breast health education, Latino women, Group education, Breast cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: Atrium Health Levine Cancer Institute
Study start: Jul 2014
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 31 Jul 2014 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Living Room Visit participants	Other	Other: Breast Health EducationLatino women who received breast health education while attending a Living Room Visit.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Latino
Female
At least 18 years old
Resident of Union County or Mecklenburg County, North Carolina

Key exclusion criteria (4 listed)

Non-Latino
Male
Less than 18 years old
Not a resident of Union County or Mecklenburg County, North Carolina

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
Breast Health EducationSmall group breast health educational sessions for Latino women in home setting.	Other	Living Room Visit participants

Primary outcome

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention).
Time frame: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.
Participants completed 25-item questionnaires requiring True/False responses to evaluate breast health knowledge at Baseline and Post-Intervention. True/False responses were recoded as being correct or incorrect, resulting in 25 unique 2x2 contingency tables of paired, dichotomous survey responses. Reported here are the frequencies of paired subject responses for each question on the Baseline and Post-Intervention questionnaires. Questions are listed below as Row Titles. Abbreviations to note include: Question: Q Mammography, Mammogram: MAM Breast cancer: BC True/False: T/F

1 secondary outcome

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Three Months After the Intervention to Assess Retention (i.e., 3-Month Contact)
Time frame: Baseline to 3-Month Contact; duration is approximately three months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Living Room Visit Participants	329	223

Primary outcome: The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention).

Time frame: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.. Count of participants. Unit: Participants

Measure	Living Room Visit Participants n = 329
Q1: MAM is screening that helps doctors look for BC so it can be found early enough to be cured, T/F: Answered incorrectly at Baseline and answered correctly at Post-Intervention	9
Q1: MAM is screening that helps doctors look for BC so it can be found early enough to be cured, T/F: Answered incorrectly at Baseline and answered incorrectly at Post-Intervention	0
Q1: MAM is screening that helps doctors look for BC so it can be found early enough to be cured, T/F: Answered correctly at Baseline and answered incorrectly at Post-Intervention	8
Q1: MAM is screening that helps doctors look for BC so it can be found early enough to be cured, T/F: Answered correctly at Baseline and answered correctly at Post-Intervention	312
Q2: MAM is done to stop BC from happening, T/F: Answered incorrectly at Baseline and answered correctly at Post-Intervention	142
Q2: MAM is done to stop BC from happening, T/F: Answered incorrectly at Baseline and answered incorrectly at Post-Intervention	64
Q2: MAM is done to stop BC from happening, T/F: Answered correctly at Baseline and answered incorrectly at Post-Intervention	15
Q2: MAM is done to stop BC from happening, T/F: Answered correctly at Baseline and answered correctly at Post-Intervention	108

Living Room Visit Participants: p = 0.8084, McNemar
Living Room Visit Participants: p <.0001, McNemar
Living Room Visit Participants: p = 0.0036, McNemar

Population analysed: Latina women, aged 18 years or older at consent (i.e., Baseline), completing both the Baseline and Post-Intervention surveys during the health education program

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were not collected for the study as the breast health education program was unlikely to present harm to the subjects enrolled in this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Living Room Visit Participants	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Roughly 32% (32.22%) of patients were non-compliant in returning three-month phone call (due to changed contact information or study team attempted three phone call contacts as defined in protocol).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Daniel Carrizosa, MD principal investigator

Carolinas Healthcare System, Levine Cancer Institute

Anna Bawtinhimer, BSPH study director

Carolinas Healthcare System, Levine Cancer Institute

Jim Symanowski, PhD study director

Carolinas Healthcare System - Levine Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Breast Health Education in people with Breast Cancer, run by Wake Forest University Health Sciences 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 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 19 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Frequencies of Paired Responses to Identical Questions on a Survey Administered at Two Timepoints: Before the Health Education Program (i.e., Baseline) and Immediately After the Health Education Program (i.e., Post-Intervention). (time frame: Baseline to Post-Intervention, occurring the same day; duration is approximately several hours.). 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 NCT02205736.

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 19 Sep 2024.