Evidence Based Dissemination for Mammography Adherence in Safety Net Communities

NCT02296177 | Completed

• 1 other identifier: HSC-SPH-14-0269
• Study Type: interventional
• Target: 4,448
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

evidence-based intervention; mammography; underserved population

Outcome Measures

Primary Outcomes (1)

• Mammography Appointment Adherence

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

  12 months

Secondary Outcomes (1)

• Cancellations or rescheduled appointments

  12 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

ACTIVE COMPARATOR

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 34822118 DERIVED

• 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.

  PMID: 30416992 DERIVED

• 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.

  PMID: 26464110 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda Highfield

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: July 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)