NCT02205736

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2.3 years

First QC Date

July 29, 2014

Results QC Date

January 24, 2018

Last Update Submit

April 23, 2024

Conditions

Breast Cancer

Keywords

Breast health educationLatino womenGroup educationBreast cancer

Outcome Measures

Primary 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 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

    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)

    Baseline to 3-Month Contact; duration is approximately three months

Study Arms (1)

Living Room Visit participants

OTHER

Latino women who received breast health education while attending a Living Room Visit.

Other: Breast Health Education

Interventions

Breast Health EducationOTHER

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

Living Room Visit participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

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).

Results Point of Contact

Title
Dr. James Symanowski
Organization
Levine Cancer Institute at Carolinas Healthcare System
james.symanowski@carolinashealthcare.org
9804422371

Study Officials

  • Daniel Carrizosa, MD

    Carolinas Healthcare System, Levine Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Anna Bawtinhimer, BSPH

    Carolinas Healthcare System, Levine Cancer Institute

    STUDY DIRECTOR

  • Jim Symanowski, PhD

    Carolinas Healthcare System - Levine Cancer Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)