Breast Cancer Clinical Trials Education Program

Institution: San Diego State University
Investigator(s): Vanessa Malcarne, Ph.D. -
Award Cycle: 2008 (Cycle 14) Grant #: 14BB-2602 Award: $206,027
Award Type: CRC Full Research Award
Research Priorities
Community Impact of Breast Cancer>Disparities: eliminating the unequal burden of breast cancer

Initial Award Abstract (2008)

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 (2012)

The overall scientific aim of this research project was to conduct a rigorous scientific evaluation of a clinical trials education program that was anticipated to help reduce the under-representation of African American and Hispanic American women in breast cancer research studies. We conducted a randomized controlled trial (RCT) to evaluate the impact of the breast cancer clinical trials educational program we had developed in the pilot project with direction from community-based focus groups. Participants in the RCT were randomly assigned to either that program (experimental group) or a comparable, but different educational program about Community Safety/Neighborhood Watch (control group).

We hypothesized that African American and Hispanic American women in the experimental group would demonstrate statistically significantly greater clinical trials knowledge, positive attitudes toward clinical trials participation, and subsequently demonstrate greater research study participation and engagement in clinical trials advocacy than the control group. Participants (n = 422), included: Hispanic American women with English as their preferred language (n = 140); Hispanic American women with Spanish as their preferred language (n = 141); and African American women (n = 141). After completing the baseline surveys, intervention and post-intervention surveys, each participant was then offered the opportunity to participate in a breast cancer-aligned cortisol study which served as a proxy measure of behavioral change related to clinical trials participation. Lastly, they were each offered the opportunity to become Clinical Trial Ambassadors, as another measure of behavioral change.

The results from the RCT supported the hypothesis that African American and Hispanic American women in the experimental group would demonstrate statistically significantly greater clinical trials knowledge after seeing the clinical trials education program. There was a significant increase in knowledge between the pre- and post-test (p < .001). There was also beneficial change in clinical trials attitudes related to personal benefit (p < .001), trust in clinical trials and researchers (ps < .001), and familiarity with clinical trials and how to access clinical trials for the experimental, but not the control group. As expected, the intervention did not significantly increase participants’ perception of community support for clinical trials in the experiment compared to the control group (p > .05). Behavior change toward breast cancer clinical trials participation and advocacy as a result of the BCCT was measured by inviting each participant to participate in a breast cancer-aligned cortisol study. They were also each offered the opportunity to become a Clinical Trials Ambassador. Participation for both groups was high, but there were no significant differences (ps > .05) between the experimental and control group.