Cancer Control Research5R03CA130598-02
Bylund, Carma L.
ENHANCING INFORMED CONSENT IN CANCER CLINICAL TRIALS;DEVELOPMENT AND EVALUATION O
DESCRIPTION (provided by applicant): Doctor patient communication about clinical trials is problematic. Increasing patient participation in consultations is associated with better patient outcomes. One method that has demonstrated significant promise in aiding doctor-patient communication are Question Prompt Lists (QPLs). QPLs consist of a list of sample written questions separated into content categories. These simple patient interventions have not been tested in the oncology clinical trial setting. Questions vary across oncology contexts. The results of studies using context-specific QPLs suggest that they are well received by patients and increase specific types of questions asked. The pilot research proposed in this study will develop and evaluate the acceptability of a QPL specific to oncology clinical trials. The utility of this new QPL will be assessed in the clinical setting using a novel measure, the question match ratio. The specific aims of this exploratory study are to; 1) develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients and 2) explore the utility of the QPL for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial. In stage 1 of the proposed study, (i) lung, breast and prostate cancer patients and their carers and (ii) health care professionals, will participate in separate focus groups to help develop and explore the acceptability of a QPL for Clinical Trials Question list. A qualitative analysis expert will analyze these data. This analysis will inform a final version of the QPL. Stage 2 of the project involves pilot testing the QPL in a sample of lung, prostate and breast cancer patients to explore the utility of the question list and patient satisfaction with the consultation. Prior to their clinical trial, patients will be asked to use the QPL by circling questions they would like to ask. They will complete pre- consultation information and involvement preference scales and post consultation achievement of involvement preferences and satisfaction with the consultation scale. The consultations will be audiotaped, transcribed and coded and these data analyzed using a new measure, the Question Match Ratio. This ratio will be compared with patient satisfaction and preference data to determine the utility of the QPL. It is anticipated that these data will be used to establish the acceptability and utility of the QPL in oncology clinical trial context and providing an evidence base for a proposed randomized clinical trial of the QPL. Patient-doctor communication is often problematic as patients commonly misunderstand trial information and do not achieve their preferences for decision involvement. By creating a question prompt list specifically for discussions concerning clinical trials, patients will gain a better understanding of the clinical trial process and therefore feel more comfortable with the accrual process. This could improve accrual rates as well as communication between doctors and patients.