Breast - FemaleNCT03162887
Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
A study testing Educational Intervention, Counseling and Informational Intervention in people with Breast - Female, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot clinical trial studies how well an educational module and decision counseling program works in increasing mammography screening rates in formerly homeless women with serious mental illness. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast - Female
- What is being tested?
- Educational Intervention, Counseling and Informational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2014to 11 Aug 2016
- 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
- 30 formerly homeless women with a diagnosis of a serious mental illness in the Pathways to Housing or Project HOME supportive housing programs
- Only women that have never received a mammogram are eligible to participate (self-report)
- Participants must be willing to participate in all aspects of research
Who cannot join
- Participants cannot be decisionally impaired, actively psychotic, or have unstable mental illness that prevents participation in the decisional counseling session
- Women who have had a mammogram will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness
This pilot clinical trial studies how well an educational module and decision counseling program works in increasing mammography screening rates in formerly homeless women with serious mental illness. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Increase mammography screening rates in women age 40 and over with experiences of homelessness and serious mental illness (SMI).
II. Increase knowledge, decease psychological distress, and advance decision stage and intention to get a mammogram in study participants.
- Conditions
- Breast - Female
- Being tested
- Educational Intervention, Counseling, Informational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Intervention through Education
Receive a research team member-led breast cancer and mammogram educational module
CounselingOther
Also called Counseling Intervention
Undergo a web-based decision counseling session
Informational InterventionOther
Receive a "next steps" document
| Study group | Role | What they receive |
|---|---|---|
| Screening (education module, counseling) | Experimental | Participants receive a research team member-led breast cancer and mammogram educational module and undergo a web-based decision counseling session over 2 hours. Participants then receive a "next steps" document and may undergo an interview to discuss their decision-making process and relevant experiences during the course of the study. Receives: Other: Educational Intervention; Other: Counseling; Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decisional conflict score assessed by pre- and post-intervention survey
Will estimate the mean pre/post change, along with a 95% confidence interval, and will test this change via a paired t-test. Will use linear regression to assess what factors (including socio-demographics and decision counseling score) are associated with the change.
Measured: Baseline up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start6 Feb 2014
- Primary completion12 Jul 2014
- Study completion11 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast - FemaleStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Lara Weinstein, MD, MPH, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162887
- Sponsor's protocol ID
- 14G.62
- Other IDs
- JT 6000, 123369-CCCDA-12-213-01-CC
- Status last verified
- May 2025
- First submitted
- 19 May 2017
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03162887
- Acronym / sponsor ID
- 14G.62
- Conditions
- Breast - Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 12 Jul 2014 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 22 May 2017 (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.
This pilot clinical trial studies how well an educational module and decision counseling program works in increasing mammography screening rates in formerly homeless women with serious mental illness. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.
Detailed description
PRIMARY OBJECTIVES:
- Increase mammography screening rates in women age 40 and over with experiences of homelessness and serious mental illness (SMI).
II. Increase knowledge, decease psychological distress, and advance decision stage and intention to get a mammogram in study participants.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (education module, counseling) | Experimental | Other: Educational Intervention, Other: Counseling, Other: Informational InterventionParticipants receive a research team member-led breast cancer and mammogram educational module and undergo a web-based decision counseling session over 2 hours. Participants then receive a "next steps" document and may undergo an interview to discuss their decision-making process and relevant experiences during the course of the study. |
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)
- 30 formerly homeless women with a diagnosis of a serious mental illness in the Pathways to Housing or Project HOME supportive housing programs
- Only women that have never received a mammogram are eligible to participate (self-report)
- Participants must be willing to participate in all aspects of research
Key exclusion criteria (2 listed)
- Participants cannot be decisionally impaired, actively psychotic, or have unstable mental illness that prevents participation in the decisional counseling session
- Women who have had a mammogram will be excluded from the study
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 |
|---|---|---|
| Educational InterventionAlso: Intervention through EducationReceive a research team member-led breast cancer and mammogram educational module | Other | Screening (education module, counseling) |
| CounselingAlso: Counseling InterventionUndergo a web-based decision counseling session | Other | Screening (education module, counseling) |
| Informational InterventionReceive a "next steps" document | Other | Screening (education module, counseling) |
Primary outcome
Change in decisional conflict score assessed by pre- and post-intervention survey
Time frame: Baseline up to 1 month
Will estimate the mean pre/post change, along with a 95% confidence interval, and will test this change via a paired t-test. Will use linear regression to assess what factors (including socio-demographics and decision counseling score) are associated with the change.
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 22 May 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lara Weinstein, MD, MPH principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Counseling and Informational Intervention in people with Breast - Female, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 2 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 22 May 2025. 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?
Change in decisional conflict score assessed by pre- and post-intervention survey (time frame: Baseline up to 1 month). 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 22 May 2025.