Breast Cancer Clinical Trials Education Program

Institution: University of California, San Diego
Investigator(s): Georgia  Sadler , Ph.D. M.B.A. - Natasha  Riley , M.A. -
Award Cycle: 2008 (Cycle 14) Grant #: 14BB-2600 Award: $158,140
Award Type: CRC Full Research Award
Research Priorities
Disparities>Disparities: eliminating the unequal burden of breast cancer

This is a collaboration with: 14BB-2601 -

Initial Award Abstract (2008)
Many factors contribute to the unequal burden of breast cancer among diverse communities. Clinical trials (research studies) offer promising solutions to medical problems and health disparities. Low clinical trials participation rates, especially among minorities, are a barrier to the advancement and generalizability of medical knowledge. Low participation by minorities is a problem because it: 1) limits researchers’ ability to apply findings to diverse populations; 2) often means that minorities will be given medical care based on research that involved mostly white middle class communities; and 3) means that cutting edge medical care options usually associated with clinical research will not be available to minorities. Such factors add to the unequal breast cancer burden among minorities. One reason why minorities do not participate in clinical trials is lack of information about clinical trials, the benefits of participation and the importance of diverse samples. This randomized controlled trial (RCT) evaluates an educational program designed to increase women’s knowledge of, positive attitudes toward, and participation in breast cancer clinical trials.

The RCT will test whether participants who receive the BCCT (experimental arm) show: 1) increased scientific knowledge about clinical trials and 2) a positive shift in attitudes about clinical trials after participating in the study. This RCT tests whether increased knowledge and a positive shift in attitudes are related to behavior change. The experimental group will be compared with a group given different information (controls). The RCT also tests whether the BCCT group demonstrates greater rates of participation in a simple breast cancer related research study than the control group. Finally, the study will see if the BCCT group demonstrates greater willingness to become a Clinical Trials Ambassador (one who learns about clinical trials and helps recruit other participants). Validated questionnaires will help measure change between the two groups and identify how personal characteristics affect response to the BCCT.

We will evaluate the BCCT with African (AA) and Hispanic American (HA) women. This program uses a “sisterhood” theme (in English and Spanish) to draw all women together against the common enemy of breast cancer. The RCT will recruit 420 women with the end goal of at least 60 HA English, 60 HA Spanish, and 60 AA English speaking women in the experimental arm, and the same distribution in the control arm, for a final sample size of 360, allowing for 15% attrition and incomplete surveys. The experimental group will be compared to the control group’s changes in knowledge and attitudes and responses to the same research study invitation. Intervention versus control participants’ responsiveness to an invitation to participate in Sadler’s Ambassadors for Clinical Trials Program will also be compared. Baseline data collection will allow the researchers to assess whether participants’ personal characteristics moderate their response to the BCCT.

There are a number of innovative elements in this research. A single program (BCCT) will educate women about breast cancer clinical trials and the importance of participation. It will produce significant improvements in women’s breast cancer clinical trials knowledge, attitudes, and behaviors and impact both AA and HA women equally. While it will use elements of the NCI’s clinical trials and breast cancer education programs, its use of “the sisterhood united against breast cancer” 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.

Community members helped focus and design the pilot study and the RCT, and they will continue to provide counsel. Community involvement will also occur when the results of this study are being disseminated and the community is being encouraged to pass along the project’s results to others. Study participants who engage in the Ambassadors Program will be involved through the ongoing dissemination of clinical trials information. UCSD and SDSU will gain additional experience working with community collaborators, expand their community connections, and ultimately increase minority women’s participation in breast cancer related research studies.

If the BCCT program is effective, it will be sent to the NCI for dissemination, presented at national meetings, and placed online for public access and for other research institutions’ use. The next research step will be to conduct an RCT in which AA and HA women who are candidates for clinical trials participation are offered 1) a standard method of informing/inviting women to take part in a clinical trial versus 2) the standard approach plus the BCCT. Another study could evaluate the program’s efficacy with Pan Asian women.