What Oncologists Believe They Said and What Patients Believe They Heard: An Analysis of Phase I Trial Discussions
- 1 January 2011
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 29 (1), 61-68
- https://doi.org/10.1200/jco.2010.30.0814
Abstract
Evaluation of the communication and informed consent process in phase I clinical trial interviews to provide authentic, practice-based content for inclusion in a communication skills training intervention for health care professionals. Seventeen oncologists and 52 patients from five United Kingdom cancer centers consented to recording of phase I trial discussions. Following each consultation, clinicians completed questionnaires indicating areas they felt they had discussed, and researchers conducted semistructured interviews with patients examining their recall and understanding. Patients and oncologists also completed the Life Orientation Test-Revised questionnaire, measuring predisposition toward optimism. Independent researchers coded the consultations identifying discussion of key information areas and how well this was done. Observed levels of agreement were analyzed for each consultation between oncologist-coder, oncologist-patient, and patient-coder pairs. In several key areas, information was either missing or had been explained but was interpreted incorrectly by patients. Discussion of prognosis was a frequent omission, with patients and coders significantly more likely to agree that oncologists had not discussed it (odds, 4.8; P < .001). In contrast, coders and oncologists were more likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .023). These data indicate that fundamental components of communication and information sharing about phase I trial participation are often missing from interviews. Important omissions included discussion of prognosis and ensuring patient understanding about supportive care. These findings will inform educational initiatives to assist communication about phase I trials.This publication has 19 references indexed in Scilit:
- Performance-based readability testing of participant materials for a phase I trial: TGN1412Journal of Medical Ethics, 2009
- Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option?Clinical Trials, 2008
- Varieties of uncertainty and the validity of informed consentClinical Trials, 2008
- Communication about cancer near the end of lifeCancer, 2008
- Purpose and Benefits of Early Phase Cancer Trials: What Do Oncologists Say? What Do Patients Hear?Journal of Empirical Research on Human Research Ethics, 2008
- The impact of an educational DVD on cancer patients considering participation in a phase I clinical trialSupportive Care in Cancer, 2006
- Patients' Decision-Making Process Regarding Participation in Phase I Oncology ResearchJournal of Clinical Oncology, 2006
- Therapeutic misconception in early phase gene transfer trialsSocial Science & Medicine (1982), 2006
- Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programmeBMJ, 2005