"Determinants Which Influence the Participation of Chinese in Cancer Screening Clinical Trials"

Jennifer Lin MD, Alyssa Finlay MD, Angela Tu MD, and Francesca Gany, MD, MS

Introduction: Ethnic minorities are underrepresented in clinical trials. Multiple recruitment barriers have been reported, including language difficulties, immigration issues, lack of physician referrals, and mistrust. However, there is a scarcity of data regarding the Chinese immigrant populations, both on accrual rates in to clinical trials and factors that influence participation. Furthermore, there are no good descriptions of possible interventions to improve recruitment in this population.
Objectives: This five stage pilot study aims to: 1) determine significant factors which influence the participation of immigrant Chinese in clinical trials, and, specifically, in cancer screening trials; 2) develop a community-based approach to address these factors and improve Chinese immigrant recruitment in to clinical trials; and 3) evaluate the effectiveness of this community-based intervention. The first stage of the study is a series of 10 focus groups with community physicians, community leaders, and community residents, both Cantonese and Mandarin-speaking. The second stage of the study is the development of a Clinical Trails Enrollment Facilitation Program (CTEFP), based on the qualitative analysis of the focus groups. The third stage is an evaluation of the CTEFP in a quasi-experimental design in two Senior Centers in Chinatown, one using usual recruitment methods, and the other with the CTEFP in place. The evaluation will track the enrollment rate into an on-going lung cancer screening trial at NYU. The fourth stage is an exit survey with Senior Center members designed to assess the CTEFP and additional factors that influenced non-participation. The final stage is the data analysis dissemination of the study findings to the medical community and to CBOs.
Results: Thus far, stages one and two have been completed. The first stage consisted of two focus groups with physicians, two groups with community leaders, two groups with Cantonese-speaking community members, and two groups with Mandarin-speaking community members. Qualitative analysis revealed that the basic understanding of clinical trials was poor and that there were many misconceptions about cancer, cancer screening, and clinical trials. Many other barriers were identified, which ranged from practical constraints of language, time, and lack of knowledge, to psychological constraints of mistrust and fears surrounding cancer. The second major area of analysis addressed strategies to inform and educate this population. In addition to newspaper, radio, and community-based interventions with the help of established organizations, community physicians were an important part of the strategy. Outreach to physicians, support staff, and community clinics has thus far been largely neglected by clinical trials at academic centers. The qualitative analysis was instructive in the creation of culturally-appropriate health education materials.
Next Steps: The CTEFP is composed of 1) trained community members called Clinical Trial Associates (CTAs) as instructors in a series of educational workshops; 2) culturally tailored health education materials (on clinical trials, and on the NYU lung cancer screening recruitment pamphlet); 3) a Cantonese/Mandarin-speaking contact person at the NYU site accessible by phone; 4) a translated study consent form, invitation letters, and instructions; and 5) appointments for the NYU study with an available interpreter. In addition, an exit survey has been developed and translated for use in the fourth stage of the study. The third and fourth stages are scheduled for late January to March 2004. The Senior Centers have been chosen, and the CTEFP and exit interviews with survey instrument will occur from late January and will finish by mid-February 2004. The Senior Centers serve approximately 600 persons a day, ages 60 to 90+, mainly Cantonese speaking. Appointments for enrollment into the NYU lung cancer screening study are blocked for the first two weeks in March. The final data analysis will be complete by April 2004.
Publication: The qualitative analysis findings from the focus group, titled “Findings from the Chinese Immigrant Community: A Qualitative Analysis of 10 Focus Groups on Cancer Screening and Clinical Trials” is being written for publication in 2004.