Principal Investigator	PI Home Department	Source of Support	Dates	Total Cost
Primo N. Lara, M.D.	Hematology and Oncology	National Cancer Institute	9/01/2003 - 8/31/2006	$218,323

The proposed study seeks to undertake a “bottom-up” approach to addressing interactional “breakdown” as a critical component of understanding and eliminating (or at least mitigating) barriers to early phase clinical trials. Detailed observations of the process of patient recruitment and participation in early phase trials will be used to validate the consent study observations and identify important elements related to the accrual process. Focus group interviews with diverse subgroups will provide both qualitative and quantitative information about differences in perceptions of important recruitment-related elements, which will be compared and summarized for each group and compared across groups. Differences will point to potential “breakdown” in interaction and will guide the design and implementation of a micro-level, communication-based intervention. We will then implement the intervention and evaluate its efficacy.

We conducted three months of intensive observation of recruitment, consent, and participation in early phase trials. These observations were used to validate findings about essential elements to trial accrual, obtained during a pilot study. The observational method and involved detailed notes describing processes and persons important to providing information relevant to diagnosis, clinical trials and their alternatives, and trials accrual. Four areas were identified as important thematic components of the accrual process: Presentation of potential subjects, Information about trial and therapies, Identification of criteria for participation, Specification of parameters for the trial, and Administration of therapies and monitoring. Elements key to these thematic components were listed with pictures on a series of cards to be used in a card sort task exercise aimed at ranking the most important through the least important elements of clinical trial accrual from the perspectives of the various parties involved in the accrual process.

To date, we have conducted 3 focus groups (CRAs, Family, and Patients) consented Research M.D.'s for interview. Interview consent forms and card sort packets have been sent out to Community M.D.'s in the UC Davis Cancer Center’s general catchment area. Research M.D.'s (n=12), CRAs (n=10), family members (n=6), and patients (n=5) have also completed the card sort task of elements important to trial accrual. Card sort data showed the three most salient processes related to accrual to clinical trials were (patient) discussion with the oncologist, direct referral to the Cancer Center, and explanations of different therapies and available options. The following processes were identified as the least important to the trial accrual in the overall card sort task: access to the Internet, information from a cancer organization, and having a sample consent form, and having a record of other patients’ concerns and progress. Discussion with the oncologist was one of the most important factors in accrual to trials. Although all parties discussed the significance of CRAs to trial accrual and retention during interviews, only patients ranked CRAs as one of the most important elements in accrual process (patients ranked CRAs as the most important element of the process). Access to the Internet and general information from Cancer organizations were considered among the least important elements influencing trial accrual. While preliminary, these findings imply that tailored (non-electronic) information is important to potential success of a communication-based intervention.