Clinical Trials Education and Access for Underserved Women

Institution: University of California, San Francisco
Investigator(s): Galen Joseph, Ph.D. - Maria Caprio,  -
Award Cycle: 2011 (Cycle 17) Grant #: 17AB-1500 Award: $74,875
Award Type: CRC Pilot Award
Research Priorities
Community Impact of Breast Cancer>Disparities: eliminating the unequal burden of breast cancer

This is a collaboration with: 17AB-1501 -

Initial Award Abstract (2011)

Introduction:  Although the inclusion of minorities and women in federally funded clinical research is mandated by law, many barriers prevent minority and poor women from participating in breast cancer trials, including the lack of information and access to trials by patients and their providers. Disparities in clinical trials (CT) information and access are not only a matter of fairness–patients should have the opportunity to participate if they wish—they are also a matter of science: without the participation of members of all groups, it is unclear if the treatments developed are effective for all people. Shanti Lifelines Breast Cancer Program (Shanti BCP), a trusted community based organization (CBO) that provides critical health navigation services to ethnically diverse low-income breast cancer patients and survivors initiated the proposed research collaboration with UCSF researchers and BreastCancerTrials.org (BCT.org), a web-based non-profit clinical trials matching service, to address the lack of culturally and linguistically appropriate information about CT for their underserved clients and for Shanti Care Navigators (SCN).

Question(s) or hypotheses: Our hypothesis is that Shanti BCP can leverage its critical and unique position within the breast cancer care system to address CT information disparities in the underserved breast cancer population in San Francisco. In the pilot study, we will conduct formative research to develop the educational materials, educational approach and the protocol for navigator-facilitated trials access (via BCT.org) that we will need to test our hypothesis in the follow up full three-year study.

General methodology: This study will use multiple qualitative methods to conduct the formative research proposed here. We will interview breast cancer care providers (doctors, social workers and hospital-based patient navigators) who interact with SCN and clients to learn about their receptivity to the idea of SCN providing CT education and access via BCT.org. Through in-depth individual interviews with SCN and Shanti BCP clients, we will learn how they view and understand CT.  We will develop educational materials in collaboration with the SCN and test them in focus groups with Shanti BCP clients. And finally, we will pre-test a protocol in which SCN provide information to clients about CT in general, and then offer to sign them up for the BCT.org trial matching service in order to gain access to specific trials for which they may be eligible.

Innovative elements: Our approach to CT information disparities is innovative in that we will build upon the critical and unique place of a trusted CBO (Shanti BCP) in the overall care system for underserved women. The multi-lingual staff at Shanti BCP share the language and culture of the lay community, provide emotional and practical support to the lay community throughout the most trying aspects of treatment, and participate in health-education and wellness activities with clients as they complete treatment and move into survivorship. Clients have come to rely upon their SCN as trusted advocates because of how SCN consistently and effectively bridge the gap between medical and non-medical support services (including transportation, food and shelter), and how they provide emotional support in non-directive, non-judgmental ways.

Community involvement: The proposed study will involve the participation of two related communities:  (1) SCN who are fluent in Mandarin, Cantonese, Spanish and English, and who provide culturally and linguistically competent one-on-one Care Navigation, including both the emotional and practical support clients need to keep up with their breast cancer treatments; (2) Shanti BCP clients, i.e. breast cancer patients/survivors, the majority of whom are poor, have limited English proficiency and are socially marginalized. For this pilot, we will focus on Shanti BCP clients who have received Shanti BCP navigation services for at least 6 months in order to examine how best to deliver CT education and access with women who are not in crisis and who have established long-term, trusting relationships with their SCN.

Future Plans: In the follow-up CRC Full Study, we will examine the educational materials and protocol for navigator-facilitated access to BCT.org developed during the pilot for efficacy in 1) improving CT information access; 2) increasing CT knowledge and understanding; and 3) moving breast cancer survivors from “not engaged/resistant to CT information” to “engaged and using BCT.org to learn about CT.”




Final Report (2013)

Medically underserved breast cancer patients lack culturally and linguistically appropriate information about clinical trials and access to participation in clinical trials. The Shanti Project’s Breast Cancer Program (Shanti BCP), a trusted community based organization (CBO) that provides critical health navigation services to ethnically diverse low-income breast cancer patients and survivors initiated this research collaboration with UCSF researchers and BreastCancerTrials.org (BCT.org), a web-based non-profit clinical trials matching service, to address this gap in information and access. Our study was designed to assess the potential role of Shanti BCP as a source of culturally appropriate education and access to clinical trials. Our hypothesis was that Shanti BCP can leverage its critical and unique position within the breast cancer care system to address health research information disparities in the underserved breast cancer population in San Francisco.

To examine our hypothesis, we initially conducted formative research including key informant interviews with providers in the San Francisco breast cancer care system to gauge their views on the role of SCN in the care system and their potential to provide clinical trials information/education to their breast cancer patients and survivors. Formative research also included in-depth interviews with the navigators and clients to obtain their perspective on clinical trials and health research overall, and to gain a better understanding of how navigators could integrate provision of health research information in a manner that is consonant with their role, their trusted relationships with clients, the Shanti care model and the logistics of their workflow. Based on the results of the formative interviews, we designed the Health Research Engagement Intervention (HREI) for Shanti Care Navigators (SCN) to deliver to their clients and a protocol for navigator-facilitated access to breastcancertrials.org. HREI for pilot testing. The HREI consists of 5 components: (1) explanation of health research and its value to the breast cancer community; (2) a “health research resource card” listing resources where patients can obtain information independently; (3) a brief health questionnaire to identify appropriate studies; (4) a tailored list of appropriate research studies from BCT; (5) navigator review of study descriptions. The pilot, conducted in English, Spanish and Cantonese with 12 Shanti clients was well received by both navigators and clients.

The research and development process utilized to create the HREI and associated materials provides the basis for the Specific Aims of the Full CRC we proposed in our March 2013 application. The first aim addresses systems barriers we identified (e.g. language and literacy) at BCT. The second aim tests the HREI protocol with a larger sample to measure statistical significance of its effects. The significance of our study lies in the increased knowledge about how underserved patients view clinical trials and how education about trials and access to trials can be provided to them in a culturally appropriate manner. A full scale test of our intervention in a follow up study to this pilot could show, if our intervention is effective, a decrease in CT information disparities, and could establish a protocol whereby patient navigators can provide access to CT information and online CT matching services such as BCT.org that are otherwise out of reach to many underserved patients.



Educating Low-SES and LEP Survivors About Breast Cancer Research: Pilot Test of the Health Research Engagement Intervention
Periodical:Journal of Cancer Education
Index Medicus:
Authors: Nickell, A., Burke, N.J., Cohen, E., Caprio, M., Joseph, G.
Yr: 2014 Vol: 29 Nbr: Abs: Pg:746-52