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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04348123
Collaborator
(none)
100
1
1
28.6
3.5

Study Details

Study Description

Brief Summary

The purpose of this study is to identify interventions that are designed to better serve women who are homeless, with a speciļ¬c 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

Condition or Disease Intervention/Treatment Phase
  • Other: Survey
  • Behavioral: Education Session
N/A

Detailed Description

The goal of this program will be to bring 6-8 mobile on site mammography clinics to homeless shelters that house women across the greater Cleveland and surrounding communities 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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Proposed Community-Based Interventional Program That Educates, Identifies And Overcomes Barriers to Complete Screening Mammography Among Homeless Women
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of women agreeing to outreach educational program [At intervention, an average of 30 minutes]

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

Secondary Outcome Measures

  1. Baseline mammogram screening rate [At intervention, an average of 30 minutes]

    Baseline mammogram screening rate of target population prior to enrollment in the program.

  2. Prevalence of social barriers to cancer screening [At intervention, an average of 30 minutes]

    Identify the prevalence of unique social barriers (top 3 collected will be reported) to cancer screening and prevention amongst the homeless population

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 in the greater Cleveland area

Exclusion Criteria:
  • Resident at a homeless shelter or transitioning housing facility in the greater Cleveland area

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio United States 44195

Sponsors and Collaborators

  • Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Chirag Shah, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT04348123
Other Study ID Numbers:
  • CASE10119
First Posted:
Apr 15, 2020
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 27, 2022