Evaluation of an information booklet for patients considering participation in phase I clinical trials in cancer.
Phase I trials in cancer patients, although essential, are a difficult field of clinical research. A particularly challenging area for all members of the clinical research team is that concerned with information-giving and informed consent leading to patient participation in the trial. An information booklet for patients was written in an attempt to address some of those issues, with the overall aim of improving the informed consent process and influencing patient decision-making. Questions covered in the booklet include: What is a phase I trial? Who can take part? Are there any side-effects or risks involved? What if I say no? The booklet was given to patients prior to consent. On the first day of receiving treatment they were given a questionnaire to evaluate the usefulness and acceptability of the booklet. The results showed the booklet to be generally well accepted by patients and the majority of them perceived the content and volume of information to be appropriate. The booklet did support patient decision-making and the evaluation showed that the optimal time for patients to receive it was prior to the signing of a consent form. Minor amendments have been made to the booklet, which is now given routinely to all patients at the cancer centre who are considering participation in a phase I trial, and is a valuable addition to the informed consent process.
Hutchison
C
C
Western Infirmary, Dumbarton Road, Glasgow, UK.
Campbell
S
S
D017321:Clinical Trials, Phase I as Topic; D006801:Humans; D007255:Information Services; D007258:Informed Consent; D009369:Neoplasms / Q000628:therapy*; D010353:Patient Education as Topic / Q000379:methods*; D011795:Surveys and Questionnaires