Evidence Based Dissemination for Mammography Adherence in Safety Net Communities

Breast Cancer Clinical Trial

Official title:

Evidence Based Dissemination for Mammography Adherence in Safety Net Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296177
• Other study ID #: HSC-SPH-14-0269
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 2018

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. However, disparities continue to exist across the breast cancer continuum for underserved women, particularly minority women. The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020 and the National Cancer Institute. However, the preventable burden of late stage breast cancer will continue until the investigators close the gap between what is known about prevention and what is implemented in the community. Although many sources of information exist about theory and [theory-] and evidence-based interventions (EBIs) to promote mammography screening, their adoption and use in the community has been limited and haphazard at best.

Description:

In order to effectively reach underserved women and reduce breast cancer disparities, D&I efforts should target the healthcare delivery system where these women receive service - the so called "safety net". Within the safety net, federally qualified health centers (FQHCs), provide comprehensive primary health care services for underserved communities regardless of ability to pay, including mammography screening. Our team has successfully pilot tested a National Cancer Institute research tested intervention program (RTIP) with underserved women and were able to reduce no-show rates from 44% to 19%. In order to accelerate the adoption and implementation of our EBI within the safety net, the investigators will use a two-step approach based on the consolidated framework for implementation research (CFIR), and intervention mapping. The investigators will actively disseminate the EBI through a unique breast health collaborative with a wide membership of FQHCs, support implementation through training and evaluate the adoption, implementation, sustainment and effectiveness of the EBI. The investigators will use a clinic clustered stepped wedge design for implementation in FQHCs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4448
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Underserved as defined by income <=200% of the federal poverty level for a family of four

• Uninsured

• In need of mammography screening; has received clinical breast exam and referral to screening

• Has upcoming screening appointment

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Peace of Mind Program
The Peace of Mind Program (PMP) is a telephone counseling program based on the Transtheoretical Model of Change, with messages matched to readiness (assessed with a stage of change question)and barriers identified by women who are non-adherent to mammography. The program telephone protocol guides counselors to assess a woman's readiness to be screened and counsel her through barriers to increase appointment keeping.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammography Appointment Adherence	Appointment attendance will be taken from the electronic health record for both control and intervention patients	12 months
Secondary	Cancellations or rescheduled appointments	Patients who cancelled and rescheduled will be taken from the electronic health record for both control and intervention patients	12 months