Communicating about Clinical Trials: Bringing the Cancer Information Service (CIS) to the Underserved [I]

Investigator: Nancy Burke, PhD
Sponsor: NIH National Cancer Institute

Location(s): United States


Public hospital patients, often of low socioeconomic status and diverse race/ethnicity (the "underserved"), have few options for understanding and managing their illness, and they are also underrepresented in clinical trials. The National Cancer Institute's Cancer Information Service (CIS), a source of high quality cancer information for the public has gone largely unused by those most in need. Specific Aims: To provide appropriate clinical trials information to support public hospital patients making informed decisions about their treatment, this study has three specific aims: 1. to assess and document clinical trial information needs of African American, Latino, and White public hospital cancer patients; 2. to assess and adapt the CIS standard of service regarding clinical trial information through modification of current CIS telephone response for low literacy and diverse cultures and development of a proactive telephone protocol to improve caller question asking skills, increase information efficacy, and encourage participation in clinical trials; and 3. To pilot test the new adapted protocol for feasibility and efficacy. This study consists of two phases. In Phase 1 multiple qualitative methods will be used to understand clinical trial information needs and to develop and pretest enhanced CIS protocols. We will gain insight into meanings patients attribute to clinical trials and 'research', document language patients use to discuss clinical trials and experimental treatments, and observe effective communications and miscommunications around provider/patient clinical trial information sharing through direct observations and ethnographic interviews. We will adapt/develop culturally appropriate protocols through: i) review of standard CIS clinical trials training; ii) prompted calls by patients to the CIS followed by patient and phone specialist debriefing interviews; and iii) patient focus groups. In Phase II we will pilot test the adapted protocols for feasibility and efficacy using pre- and post-call interviews. The conceptual framework is drawn from Subjective Culture, Informed Decision-making, and Social Learning Theories. Increasing participation of minorities in clinical trials research has been identified as a means to address cancer disparities. Recent research suggests that minorities are as willing as non-Hispanic whites to participate in clinical research if given appropriate information and opportunity. Building upon a pre-existing, federally funded cancer information resource (CIS), this study aims to bring appropriate cancer clinical trials information to underserved cancer patients and their families who need it the most.