NCT04348123

Brief Summary

The purpose of this study is to identify interventions that are designed to better serve women who are homeless, with a specific focus on increasing screening rates and decreasing late stage breast cancer diagnosis among this high-risk understudied community of women. As a result, the study team hopes to influence the broader homeless healthcare initiative

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2022

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

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

April 13, 2020

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of women agreeing to outreach educational program

    Rate of women approached who agree to enter the outreach educational program

    At intervention, an average of 30 minutes

Secondary Outcomes (2)

  • Baseline mammogram screening rate

    At intervention, an average of 30 minutes

  • Prevalence of social barriers to cancer screening

    At intervention, an average of 30 minutes

Study Arms (1)

Outreach educational program

EXPERIMENTAL

Participants will be given a survey to elucidate beliefs and barriers around breast health and mammography. A brief, culturally-appropriate educational session about breast health and mammography will follow and will be delivered by a female public health educator. After education, eligible women will be offered a free on-site mammogram

Other: SurveyBehavioral: Education Session

Interventions

SurveyOTHER

Survey questionnaire seeks to collect data relevant to mammogram completion, barriers, and facilitators

Outreach educational program

After the survey, clinic staff will conduct brief, culturally-appropriate educational session about breast health and mammography delivered by a female public health educator with experience in the underserved community. Educational session will explain screening options and address common barriers

Outreach educational program

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women under age 40 who present with high risk breast cancer related symptoms or a first degree relative with breast cancer
  • Have not had mammogram in the last 12 months
  • Resident at a homeless shelter or transitioning housing facility.

You may not qualify if:

  • \- Participant experiencing homelessness under age 40 who DO NOT present with high risk breast cancer related symptoms or a first degree relative with breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Heather Hurwitz, PhD

    Cleveland Clinic, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

March 15, 2022

Primary Completion

December 16, 2024

Study Completion

December 16, 2024

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

This is a study to increase screening and will be studied as a population

Locations