Clinical trial NCT02296177: Evidence Based Dissemination for Mammography Adherence in Safety Net Communities
Official title: Evidence Based Dissemination for Mammography Adherence in Safety Net Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: evidence-based intervention
mammography
underserved population
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-11-20
Enrollment: 4448
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Mammography Appointment Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Cancellations or rescheduled appointments
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Linda Highfield
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.