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CompletedNCT03162887Updated May 22, 2025

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

An interventional study of Educational Intervention and Counseling in Breast - Female, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Feb 2014, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
40 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast - Female
03

In context

Lead sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 120 studies on the registry; none are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • 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 · Other: Counseling · Other: Informational Intervention

Interventions

  • OtherEducational Intervention

    Receive a research team member-led breast cancer and mammogram educational module

    Also known as: Intervention through Education

  • OtherCounseling

    Undergo a web-based decision counseling session

    Also known as: Counseling Intervention

  • OtherInformational Intervention

    Receive a "next steps" document

06

What researchers measure

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.

    Time frame: Baseline up to 1 month

07

Study locations

1 site
  • Sidney Kimmel Cancer Center at Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03162887
Collaborators
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
May 22, 2017
Start date
Feb 6, 2014
Primary completion
Jul 12, 2014
Completion
Aug 11, 2016
Last update
May 22, 2025

Study contacts

Lara Weinstein, MD, MPH
principal investigator · Sidney Kimmel Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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