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OpenTrials
Completed

NCT Number: NCT02296177

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

-

Treatment and study plan

Peace of Mind Program

Behavioral

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.

Primary outcomes

  1. Mammography Appointment Adherence

    Time frame: 12 months

    Appointment attendance will be taken from the electronic health record for both control and intervention patients

Secondary outcomes

  1. Cancellations or rescheduled appointments

    Time frame: 12 months

    Patients who cancelled and rescheduled will be taken from the electronic health record for both control and intervention patients

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2014
Registry last updated
Dec 8, 2023

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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