Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness
3 other identifiers
interventional
23
1 country
1
Brief 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. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2016
CompletedFirst Submitted
Initial submission to the registry
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedMay 22, 2025
May 1, 2025
5 months
May 19, 2017
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Screening (education module, counseling)
EXPERIMENTALParticipants 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.
Interventions
Receive a research team member-led breast cancer and mammogram educational module
Undergo a web-based decision counseling session
Receive a "next steps" document
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Weinstein, MD, MPH
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 22, 2017
Study Start
February 6, 2014
Primary Completion
July 12, 2014
Study Completion
August 11, 2016
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share