Interventional Program Educates, Identifies + Overcomes Barriers to Complete Screening Mammography

A Proposed Community-Based Interventional Program That Educates, Identifies And Overcomes Barriers to Complete Screening Mammography Among Homeless Women

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Survey; Behavioral: Education Session

Detailed Description

The goal of this program will be to bring 6-8 mobile on site mammography clinics to homeless shelters that house women over a two-year period. Prior to arrival, clinic staff will recruit women to participate in a survey to elucidate beliefs and barriers around breast health and mammography. After the survey, clinic staff will conduct the outreach program, consisting of a brief educational session about breast health and mammography for any participating women. Education will be tailored to be culturally appropriate, and delivered by a female public health educator with experience in the underserved community. The educational session will explain screening options and address common barriers. After education, eligible women who wish to receive a mammogram may receive one from the on-site mobile mammography clinic free of charge. Throughout the day, the community educator will also lead activities and meals will be provided in order to create a festive atmosphere and inspire a sense of community among the women. Spanish speaking staff will be available for the educational sessions.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Outreach educational program; 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: Survey; Survey questionnaire seeks to collect data relevant to mammogram completion, barriers, and facilitators; Behavioral: Education Session; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline mammogram screening rate	Baseline mammogram screening rate of target population prior to enrollment in the program.	At intervention, an average of 30 minutes
Prevalence of social barriers to cancer screening	Identify the prevalence of unique social barriers (top 3 collected will be reported) to cancer screening and prevention amongst the homeless population	At intervention, an average of 30 minutes

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Heather Hurwitz, PhD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: CASE10119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a study to increase screening and will be studied as a population

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No