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NCT Number: NCT03162887

Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in 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.

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Key information

Conditions

Breast - Female

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

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

Other names: Intervention through Education

Counseling

Other

Undergo a web-based decision counseling session

Other names: Counseling Intervention

Informational intervention

Other

Receive a "next steps" document

Primary outcomes

  1. Change in decisional conflict score assessed by pre- and post-intervention survey

    Time frame: Baseline up to 1 month

    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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
May 22, 2017
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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