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

Breast - Female Clinical Trial

Official title:

Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162887
• Other study ID #: 14G.62
• Status: Completed
• Phase: N/A
• First received: May 19, 2017
• Last updated: May 19, 2017
• Start date: February 6, 2014
• Est. completion date: August 11, 2016

Study information

• Verified date: May 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. An educational module and decision counseling program may be an effective tool and have the potential to help with early detection and treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 11, 2016
• Est. primary completion date: July 12, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast - Female
• Mental Disorders

Intervention

Other:
• Educational Intervention
Receive a research team member-led breast cancer and mammogram educational module
• Counseling
Undergo a web-based decision counseling session
• Informational Intervention
Receive a "next steps" document

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital