Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness

Study Overview
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Brief Summary
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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
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PRIMARY OBJECTIVES: I. 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.

Official Title
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Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness

Conditions
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Breast - Female

Intervention / Treatment
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* Other: Educational Intervention
* Other: Counseling
* Other: Informational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening (education module, counseling)<br>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. | Other: Educational Intervention<br>* Receive a research team member-led breast cancer and mammogram educational module<br>* Other names: Intervention through Education;Other: Counseling<br>* Undergo a web-based decision counseling session<br>* Other names: Counseling Intervention;Other: Informational Intervention<br>* Receive a next steps document<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline up to 1 month |