Evidence Based Dissemination for Mammography Adherence in Safety Net Communities

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Peace of Mind Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4448
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will receive the standard practice of care related to mammography phone call reminders. If a clinic currently conducts reminders, they will receive that standard call. If no reminders are done, then they will not receive a call during the control period.
Active Comparator: Intervention; The intervention group will receive a reminder call about their upcoming appointment that assesses their intent to attend the appointment and counsels them through barriers to attendance. The call is conducted by a trained patient navigator using an adapted NCI RTIP to increase mammography appointment adherence.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mammography Appointment Adherence	Appointment attendance will be taken from the electronic health record for both control and intervention patients	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Linda Highfield, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Holcomb J, Rajan SS, Ferguson GM, Sun J, Walton GH, Highfield L. Implementation of an Evidence-Based Intervention with Safety Net Clinics to Improve Mammography Appointment Adherence Among Underserved Women. J Cancer Educ. 2023 Feb;38(1):309-318. doi: 10.1007/s13187-021-02116-w. Epub 2021 Nov 25.
• Highfield L, Valerio MA, Fernandez ME, Eldridge-Bartholomew LK. Development of an Implementation Intervention Using Intervention Mapping to Increase Mammography Among Low Income Women. Front Public Health. 2018 Oct 26;6:300. doi: 10.3389/fpubh.2018.00300. eCollection 2018.
• Highfield L, Rajan SS, Valerio MA, Walton G, Fernandez ME, Bartholomew LK. A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women. Implement Sci. 2015 Oct 14;10:143. doi: 10.1186/s13012-015-0334-x.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimated): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: mammography; underserved population; evidence-based intervention
• Other Study ID Numbers: HSC-SPH-14-0269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO