Baylor College of Medicine

Abstract:

Principal Investigator:
Amelie Ramirez, Dr. PH
Associate Professor, Department of Medicine
Deputy Director, Chronic Disease Prevention and Control Research Center
Baylor College of Medicine 

Advances in cancer treatment are critically tied to the investigation of new therapeutic agents in early phase clinical trials. A significant barrier to progress has been the low participation rate onto these trials, especially among minority populations. Increasing minority accrual is critical to the development of novel cancer treatments. Without adequate minority participation in early phase clinical trials, researchers cannot assess differential effects among groups nor ensure the generalizability of trial results. The Chronic Disease Prevention and Control Research Center at Baylor College of Medicine will lead this project with support from the San Antonio Cancer Institute (SACI) that services a culturally and ethnically diverse population of largely Hispanics that historically has had a low participation rates onto early phase clinical trials.

The goals of this project are to:

1)     Identify the cultural, economic, and structural barriers to early phase clinical trial participation faced by patients and oncologists; and

2)     Develop effective interventions to reduce these barriers, thereby increasing participation on drug development trials.

To achieve these goals, the following are the specific aims:

1)     Identify the sociodemographic, cultural, economic, and structural patient barriers to participation in early phase clinical trials among cancer patients using qualitative methodology;

2)     Identify and quantitate the magnitude of barriers to patient referral to early phase clinical trials through semi-structured qualitative interviews with oncologists in Bexar County;

3)     Confirm these findings in a larger cancer patient population by quantitating the sociodemographic, cultural, economic, and structural barriers to participation;

4)     Design an experimental intervention trial to reduce the barriers to early phase clinical trial participation; and

5)     Conceptually evaluate that intervention among a representative group of cancer patients and oncologists.

This proposed 2-year study will involve 200 Hispanic patients and 20 oncologists in the Bexar County, Texas. Both qualitative and quantitative formative research methods will be used to collect data to assess barriers. The results of these assessment activities will guide the design of a culturally sensitive intervention trial to overcome barriers encountered by both patients and oncologists when considering patient participation in an early phase clinical trial. The intervention protocol will be reviewed by patients and oncologists and finalized in preparation for a later phase of research (outside this 2-year project period) to be implemented and evaluated in the San Antonio area.