Engaging Underserved Women in Health Research

Institution: University of California, San Francisco
Investigator(s): Galen  Joseph , Ph.D. - Alyssa  Nickell , Ph.D. -
Award Cycle: 2014 (Cycle 20) Grant #: 20BB-2100 Award: $375,000
Award Type: CRC Full Research Award
Research Priorities
Community Impact of Breast Cancer>Health Policy and Health Services: better serving women's needs

This is a collaboration with: 20BB-2101 -

Initial Award Abstract (2014)

Introduction: Underserved breast cancer patients and survivors are typically offered fewer opportunities to participate in cancer research than other women. As a result, critical life-saving treatments and quality of life services developed from the studies may not address their needs. This disparity exists despite a 1993 federal mandate to include minorities in clinical research, and significant efforts to address many documented patient, provider, and systems barriers to information about and participation in health research. Shanti Breast Cancer Program (Shanti) -- a trusted and long standing community-based organization providing critical health navigation services to ethnically diverse low-income breast cancer patients and survivors throughout the City and County of San Francisco -- initiated the collaboration that led to our recently completed CBCRP Pilot study (2011-2013). The purpose was to address the clinical trials information chasms experienced by Shanti clients. For this proposed Full study, as for our Pilot, Shanti is collaborating with UCSF faculty who have examined and documented disparities in clinical trials information and access for Bay Area breast cancer patients, and with BreastCancerTrials.org (BCT), a nonprofit resource dedicated to helping breast cancer patients and survivors find clinical trials and other health research opportunities personalized to their situation, and committed to making its services available to women regardless of language, education and computer access.

Question(s) or hypotheses: During our Pilot, we developed and pilot tested our Health Research Engagement Intervention (HREI)—in which navigators, using BCT, facilitate their clients’ awareness of and access to health research studies. We defined "health research" broadly to include behavioral, epidemiological, lifestyle intervention, and qualitative research as well as treatment trials, and we focused on post treatment breast cancer survivors and metastatic patients with stable disease to test the protocol with patients who were not in the crisis of their initial diagnosis. Our research questions are: How effective is a health research information and access intervention delivered by community based navigators in generating interest in, knowledge of and positive attitudes toward health research opportunities, and health research information seeking behavior? Can we reduce systems barriers to health research (e.g. access to literacy and language appropriate information) by building the capacity of existing key players in the breast cancer system?

General methodology: This study uses both qualitative and quantitative research methods including: (1) capacity building for the CBO partner (Shanti) and the health research access point (BCT); (2) a prospective randomized intervention trial with pre and post surveys; and (3) a process evaluation of the enhancements to Shanti and BCT and the trial intervention. Innovative elements: This is a highly synergistic partnership in that the union uses the strengths of each (Shanti and BCT) to directly address and compensate for the limitations of the other with regard to capacity to connect low-income diverse women with breast cancer research. Using these existing resources in this new and complementary way strengthens the overall care system for underserved breast cancer patients and survivors in the bay area, and is expected to efficiently and sustainably fill a persistent gap in access to health research information and participation opportunities.

Community involvement: Two related communities are involved throughout the development and implementation of this study: (1) multilingual Shanti Care Navigators who connect their clients with resources to help them keep up with their breast cancer treatments, such as money for rent, utilities and phone bills, access to free transportation and hot meals, translation services and emotional support; and who facilitate client participation in social and educational wellness activities to strengthen their engagement with the breast cancer community and their capacity to advocate for and manage their health. Navigators have participated in designing and will deliver the HREI protocol; and (2) post treatment survivors and metastatic patients with stable disease who are low-income, limited English speaking (LEP) Chinese and Latino, and ethnically diverse English speaking client population.

Future Plans: This study, which focuses on increasing access to health research information for post treatment breast cancer survivors and metastatic patients with stable disease, will lay the groundwork for adapting and testing our intervention with newly diagnosed breast cancer patients, and for use with other clinical trials access organizations. It will also prepare us to study the long-term effectiveness of our community education and systems interventions on research participation.




Progress Report 1 (2015)

Breast cancer patients and survivors who are living below the poverty line and are limited in their ability to speak, read or write in English have less access to information about health research than other women, and are less likely to participate in health research. As a result, the personal, social and biological factors that are unique to these underserved women are not adequately taken into account in the development and testing of treatments and quality of life services. Our team has taken a two-pronged approach to address this issue. One is patient-facing and the other addresses barriers within the wider system of care: 1) building the capacity of two key organizations in the breast care system to provide information about health research in ways that take into account the needs of women with limited English proficiency, low-literacy, and other psychosocial barriers, such as lack of trust in the medical system and concerns with privacy, and 2) providing underserved women with basic education about health research [the Health Research Engagement Intervention (HREI)], delivered by people they trust (care navigators), with the goal of increasing their capacity and behavior related to seeking information about health research on their own.

Late receipt of CBCRP funding pushed the internal start date of our study to September 1, 2014. As of the end of the third quarter of year 1, we are on-track to complete our specific aims according to our proposed three-year timeline. The following is a summary of our major accomplishments related to our specific aims. (Aim 1) Capacity building. In year 1, we increased the capacity of Breast Cancer Trials.org (BCT), a health research information access portal, to provide information about health research in Spanish and Cantonese by phone through an interpreter, and supported BCT in making its website easier for underserved women to navigate by simplifying the layout and the language, including highlighting BCT’s help line in Spanish, Cantonese and English. We also increased the capacity of our community-based partner, Shanti Project (Shanti), to conduct research and deliver information about health research to patients by securing Shanti’s access to published literature via UCSF’s library system and by providing multiple trainings for Shanti Care Navigators on health research in general, survey development and testing, delivering the HREI, and conducting the trial to test the effectiveness of the HREI among their Spanish-, English- and Chinese-speaking patients.

(Aim 2) Randomized controlled trial of HREI. In the year 1, we reviewed, revised and finalized all the materials necessary for delivery of the HREI. In addition, we developed all the trial materials, including consent forms, pre- and post-intervention surveys, the BCT help-line phone system and data tracking forms. The care navigators began to recruit patients into the trial on May 1, 2015.

Barriers related to study protocols were minimal. Shanti care navigators expressed concerns about their capacity to conduct survey pre-testing and BCT usability testing. To address this concern, other members of the research team conducted all pre-testing of trial materials and BCT enhancements.

In the coming year, we will continue to recruit and conduct the HREI trial. Shanti care navigators will receive on-going education on health research throughout the length of the study and beyond. Patients will be enrolled into the trial through the end of February 2016, followed by data analysis and dissemination of results by the UCSF-Shanti-BCT research team. If findings show that the HREI is effective among patients accessing Shanti’s care navigation services in increasing their capacity and behavior related to seeking information about health research on their own, the HREI will become part of Shanti’s suite of services delivered to underserved women living with breast cancer.




Progress Report 2 (2016)

Breast cancer patients and survivors who are living below the poverty line and are limited in their ability to speak, read or write in English have less access to information about health research than other women, and are less likely to participate in health research. As a result, the personal, social and biological factors that are unique to these underserved women are not adequately taken into account in the development and testing of treatments and quality of life services. Our team has taken a two-pronged approach to address this issue. One is patient-facing and the other addresses barriers within the wider system of care: 1) building the capacity of two key organizations in the breast care system to provide information about health research in ways that take into account the needs of women with limited English proficiency, low-literacy, and other psychosocial barriers, such as lack of trust in the medical system and concerns with privacy, and 2) providing underserved women with basic education about health research [the Health Research Engagement Intervention (HREI)], delivered by people they trust (care navigators) with the goal of increasing their capacity and behavior related to seeking information about health research on their own. We are making excellent progress toward completion of our aims. The following is a summary of our major accomplishments and strategies to date.

(Aim 1) Capacity building. In year 2, Breast Cancer Trials.org (BCT) implemented a multilingual (English, Cantonese, and Spanish) voicemail system and enhanced BCT’s website to provide information in a format more accessible to lower health literacy patients, including a new search box. In addition, our collaboration generated an initiative, funded from Susan G. Komen for the Cure, to develop literacy guidelines for describing trials. In order to accurately and efficiently identify and track eligible Shanti clients for the study, our community-based partner, Shanti’s Margot Murphy Women’s Cancer Program (Shanti), created and implemented a Shanti Client Tracking Calendar. All Shanti Care Navigators currently complete the calendar which lists the expected recruitment date for each eligible client. The calendar is continuously updated in real-time to ensure that six-month projections of enrollment numbers are accurate. We continue to provide trainings for Shanti Care Navigators, and in year three they will receive continuing education on health research. Our goal is to ensure that these capacity building enhancements are sustainable beyond the grant cycle.

(Aim 2). Randomized controlled trial of HREI. Shanti Care Navigators began to recruit patients into the trial on May 15, 2015. As of May 31, 2016 more than half (89 of 150) of the needed RCT participants were enrolled. We began by enrolling only Shanti clients who are post treatment survivors or metastatic patients with stable disease, and speak English, Cantonese or Spanish. Due to relatively low recruitment, in X month, we expanded the recruitment criteria to include all Shanti clients who speak English, Cantonese, or Spanish and have “low care navigation needs” (i.e. client may or may not still be undergoing treatment but is no longer in the crisis of initial diagnosis or burdened by treatment protocols). In addition, we conducted an interim analysis that indicated participants in the intervention group were more likely than those in the control group to seek health research information, our primary outcome. We also reviewed open-ended responses from the trial participants to explore potential topics for qualitative interviews. We are currently developing the qualitative interview guide.

In Year 3, we will complete the HREI trial and conduct the qualitative interviews, followed by data analysis and dissemination of results by the UCSF-Shanti-BCT research team. If findings show that the HREI is effective among patients accessing Shanti’s care navigation services in increasing their capacity and behavior related to seeking information about health research on their own, the HREI will become part of Shanti’s suite of services delivered to underserved women living with breast cancer.




Conference Abstract (2016)

Engaging Underserved Women in Health Research

Authors: Alyssa Nickell1, Janice Cheng2, Katie Lawlor1, Susan Stewart3, Elly Cohen2,4, Nancy Burke5, Susan Cohen2,4, Claudia Guerra2, Galen Joseph2
Affiliations: 1Shanti's Margot Murphy Breast Cancer Program; 2University of California, San Francisco; 3University of California, Davis; 4BreastCancerTrials.Org; 5University of California, Merced

Background: Underserved breast cancer patients and survivors are typically offered fewer opportunities to participate in cancer research. To address this disparity, Shanti's Margot Murphy Breast Cancer Program (Shanti) initiated a collaboration with UCSF researchers and BreastCancerTrials.org (BCT), a nonprofit clinical trials matching service that led to our successful CBCRP pilot study (2011-2013). The pilot study identified guiding principles for our Health Research Engagement Intervention (HREI): (a) within the context of a trusted relationship, navigators provide education about health research and increase access to information about ongoing breast cancer studies, emphasizing the range of treatment and non-treatment quality-of-life and observational studies; (b) provide education and information at a time when the patient is not in the initial crisis of diagnosis; and © address systems barriers to health research information and participation.

Methods: This study uses both qualitative and quantitative research methods to: (1) build capacity for the CBO partner (Shanti) and the health research access point (BCT) and to evaluate the enhancements to both; (2) conduct a prospective randomized controlled trial (RCT) of the HREI with pre and post surveys; and (3) evaluate the implementation of the trial intervention qualitatively. The primary outcome is health research information seeking behavior. Secondary outcomes include health research knowledge, attitudes towards research participation, and health empowerment.

Challenges and Strategies: To address system barriers, we added a multilingual (English, Cantonese, and Spanish) voicemail system to BCT’s helpline and enhanced the design of the BCT website for easier navigation by lower health literacy patients. We also implemented a Shanti Client Tracking Calendar to project future enrollment numbers accurately six months out. Our goal is to ensure that these capacity building enhancements are sustainable beyond the grant cycle. Thirty-five of 150 RCT participants have been enrolled to date. To increase the number of eligible participants and speed recruitment, we have expanded the recruitment criteria. We began by enrolling only Shanti clients who are post treatment survivors or metastatic patients with stable disease, and speak English, Cantonese or Spanish. Now, all Shanti clients who speak English, Cantonese or Spanish and have “low care navigation needs” are eligible (i.e. client may or may not still be undergoing treatment but is no longer in the crisis of initial diagnosis or burdened by treatment protocols).

Potential Impact: This study will synergistically improve the capacity of two breast cancer organizations to increase equity in access to health research information and research participation opportunities for diverse underserved breast cancer patients and survivors. The potential impact will be to reduce disparities in access to health research information and participation opportunities, and to produce a dissemination-ready navigator protocol with the potential for replication in underserved communities nationally. Thus, our intervention has the long-range potential to impact progress of breast cancer research.