Science Literacy & Breast Cancer Clinical Trials Education

Institution: Vista Community Clinic
Investigator(s): Natasha  Riley , M.A. - Georgia  Sadler , Ph.D. M.B.A. -
Award Cycle: 2007 (Cycle 13) Grant #: 13AB-3501 Award: $121,402
Award Type: CRC Pilot Award
Research Priorities
Disparities>Disparities: eliminating the unequal burden of breast cancer

This is a collaboration with: 13AB-3500 -

Initial Award Abstract (2007)
Many factors contribute to the unequal burden of breast cancer among diverse communities. Clinical trials or “research studies,” offer promising solutions to medical advances. Low participation rates in clinical trials, especially among minorities, are a barrier to the advancement and generalizability of medical knowledge and health impact on survivorship among these populations.

Low participation by minorities is a problem because: 1) it limits researchers’ ability to apply findings to diverse populations; 2) it often means that minorities will be given medical care based on research studies that involved mostly white middle class communities; and 3) it means that the cutting edge medical care options usually associated with clinical research will not be available to minorities. All of these factors contribute to the unequal burden of breast cancer among minorities. One reason why minorities do not participate in clinical trials is lack of information about the role of clinical trials and the importance of participants of diverse characteristics. This pilot study addresses that problem by providing an educational program to increase awareness of, and knowledge about, clinical trials information.

Research questions will not be directly tested in the pilot study. The pilot study will develop the tools needed to test the educational program to be developed. The larger study will test whether participants who receive the educational program (the experimental group) show: 1) increased scientific knowledge about clinical trials and 2) a positive shift in attitudes and behaviors toward clinical trials after participating in the study. This pilot study will also test whether increased knowledge and a positive shift in attitudes and behavior are related. The results in the experimental group will be compared with a group given different information (the control group). The larger study will also test whether the group given the educational program will demonstrate a greater rate of participation in a simple breast cancer-related research study than the control group. Finally, the study will test whether the test group demonstrates greater willingness to become a “Clinical Trials Ambassador” (one who learns about future clinical trials and helps the research team to recruit other participants). Standard questionnaires will be used to help measure change between the two groups of participants.

This project will focus on creating a single program, called the Scientific Literacy and Breast Cancer Clinical Trials Education Program. This program will be pilot tested with a group of African American and Hispanic American women. The program will use a “sisterhood” theme that will draw all women together against the common enemy of breast cancer. Building on program work already done by the National Cancer Institute, a single education program will be created in English and Spanish. This project will also test group surveys in English and Spanish to assure that they are reliable when used with Hispanic American women. These surveys have already been shown to work well with African American women. After proving the surveys’ reliability, a trial run will be performed with the educational program and surveys with a small group of women. If this plan works, a larger study will be done to determine the effectiveness of the educational program.

This pilot study will educate women about breast cancer clinical trials and the importance of participation. While it will use many elements of the NCI’s cancer education program, its use of a “sisterhood” theme as its foundation is innovative and is anticipated to appeal to women of all ethnic groups. The program will be tested in English and Spanish with Hispanic and African American women. This project will also evaluate the usefulness of a number of paper and pencil surveys when used with Hispanic Americans. These surveys are commonly used in breast cancer and other research studies, but have not yet proven effective with Hispanic Americans. If this pilot project works, a larger study will follow. If the program is effective it will be made available to other breast cancer researchers and health educators. Community involvement: Focus groups have already contributed direction on the topic and design selected for this study. Community input will continue throughout the project. Staff from the five VCC clinics that serve low income, minority women will advise the research partner. VCC will benefit by gaining research skills and experience in creating partnerships. UCSD will benefit from this partnership by gaining additional experience working with disadvantaged women and enhancing its community connections. The partnership will help both groups better serve the community.


Final Report (2009)

The "Scientific Literacy & Breast Cancer Clinical Trials Education Program (BCCT)" is designed to increase scientific literacy, clinical trials participation, and advocacy among African American and Hispanic American women. The pilot study included three phases. Phase I consisted of the validation of a series of psychosocial survey instruments with 500 Latinas (250 spoke English and 250 spoke Spanish) to determine their validity for Latinas. This was necessary prior to using the instruments as outcome measures in a subsequent study which is planned following this pilot study. Phase II involved the development of a culturally appropriate BCCT educational program with the help of focus groups composed of 80 African American and Hispanic American women. Phase III was a pilot randomized controlled educational trial of the BCCT educational intervention with 60 African American and Hispanic American women.

During this project period, the Partnership successfully achieved its goal of recruiting at least 500 Latinas (250 English and 250 Spanish) to determine the validity of a variety of psychosocial survey instruments that are anticipated to be used as outcomes measures in the randomized controlled trial that is planned to follow this three-phase pilot study. The analysis supported the validity of the new Barriers to Clinical Trials Participation scale and the other psycho-social instruments that were needed in the subsequent, definitive randomized control trial that is planned. In Phase II, the Partnership created a "sisterhood-themed" culturally appropriate BCCT educational program which is grounded on the National Cancer Institute's programs. The BCCT was translated into Spanish to permit access by monolingual Spanish speaking women. The program was tested through a series of focus groups that included 80 African American and Hispanic American women. The "sisterhood-theme" BCCT program was deemed to be an acceptable educational strategy by the focus group participants. The BCCT program was pilot tested in Phase III of this pilot study.

No major barriers were encountered during this reporting period. During Phase I of this pilot study, the partnership members worked together to validate a series of psycho-social instruments. All psycho-social instruments planned for the definitive control trial were successfully validated for use with Hispanic American women. During Phase II of this pilot study the partnership worked together to complete two consecutive rounds of focus groups which reinforced the "sisterhood theme" as a viable strategy for accrual of underrepresented women to research studies. The BCCT was developed as a self-paced Power Point presentation with voice narration, in both English and Spanish, and the final iteration of the presentation was well received by focus group members. In Phase III of this pilot study, the methodology proposed for the definitive randomized control trial was implemented and found to be problem free. Thus, the outcome measures and the methodology within which they will beused have all been proven to be satisfactory for the subsequent study that has already been approved for funding by the California Breast Cancer Research Program.

During the final phase of this pilot project, three abstracts were developed and submitted for presentation at the American Association for Cancer Education's 42nd Annual Meeting, October 20-22, 2008 in Clearwater Beach, Florida. All abstracts were accepted for podium presentations and abstracts were submitted for publication in the Journal of Cancer Education, Supplement to Volume 23, Number 3, July - September 2008. The abstracts are now being expanded and developed into manuscripts that will be submitted to peer review journals for publication. The first article has already been submitted. We anticipate that several additional articles will also be published from this database.

The data have been analyzed for the primary purpose of informing the refinement of the BCCP educational program. This rich data base will be made available to students and faculty researchers for further analysis that is anticipated to produce additional findings. The methodology that was developed and tested during this current pilot study will next be implemented for scientific testing with funding already approved from the California Breast Cancer Research Program's Community Research Collaboration (CRC) Awards Program.