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

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.

Study Overview

• Status: Completed
• Conditions: Breast - Female
• Intervention / Treatment: Other: Educational Intervention; Other: Counseling; Other: Informational Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Lara Weinstein, MD, MPH, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2014
• Primary Completion (Actual): July 12, 2014
• Study Completion (Actual): August 11, 2016

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 14G.62; JT 6000 (Other Identifier: JeffTrial Number); 123369-CCCDA-12-213-01-CC (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No