Breast CancerNCT04348123
Interventional Program Educates, Identifies + Overcomes Barriers to Complete Screening Mammography
A study testing Survey and Education Session in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Survey and Education Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Survey, Education Session
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey questionnaire seeks to collect data relevant to mammogram completion, barriers, and facilitators
Education SessionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Survey; Behavioral: Education Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women agreeing to outreach educational program
Rate of women approached who agree to enter the outreach educational program
Measured: At intervention, an average of 30 minutes
Secondary outcomes (2)
Baseline mammogram screening rate
Baseline mammogram screening rate of target population prior to enrollment in the program.
Measured: 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
Measured: At intervention, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start15 Mar 2022
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Hurwitz, PhD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348123
- Sponsor's protocol ID
- CASE10119
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a study to increase screening and will be studied as a population
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Community-Based Interventional Program That Educates, Identifies And Overcomes Barriers to Complete Screening Mammography Among Homeless Women
- ClinicalTrials.gov ID
- NCT04348123
- Acronym / sponsor ID
- CASE10119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outreach educational program | Experimental | Other: Survey, Behavioral: Education SessionParticipants 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| SurveySurvey questionnaire seeks to collect data relevant to mammogram completion, barriers, and facilitators | Other | Outreach educational program |
| Education SessionAfter 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 | Behavioural | Outreach educational program |
Primary outcome
Proportion of women agreeing to outreach educational program
Time frame: At intervention, an average of 30 minutes
Rate of women approached who agree to enter the outreach educational program
2 secondary outcomes
Baseline mammogram screening rate
Time frame: At intervention, an average of 30 minutes
Prevalence of social barriers to cancer screening
Time frame: At intervention, an average of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. This is a study to increase screening and will be studied as a population
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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.
Heather Hurwitz, PhD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey and Education Session in people with Breast Cancer, run by Case Comprehensive Cancer Center 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 3 inclusion and 1 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 30 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of women agreeing to outreach educational program (time frame: At intervention, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.