Back to resultsEducational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
Primary Purpose
Breast - Female
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Counseling
Informational Intervention
Sponsored by
About this trial
This is an interventional screening trial for Breast - Female
Eligibility Criteria
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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening (education module, counseling)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03162887
First Posted
May 19, 2017
Last Updated
May 19, 2017
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03162887
Brief Title
Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
Official Title
Mammogram Decision Support for Formerly Homeless Women With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 6, 2014 (Actual)
Primary Completion Date
July 12, 2014 (Actual)
Study Completion Date
August 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast - Female
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening (education module, counseling)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Intervention through Education
Intervention Description
Receive a research team member-led breast cancer and mammogram educational module
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Undergo a web-based decision counseling session
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive a "next steps" document
Primary Outcome Measure Information:
Title
Change in decisional conflict score assessed by pre- and post-intervention survey
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Weinstein, MD, MPH
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Educational Module and Decision Counseling Program in Increasing Mammography Screening Rates in Formerly Homeless Women With Serious Mental Illness
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