Attitudes of patients to randomised clinical trials of cancer therapy

Abstract

The aim of this study was to test an instrument which might be useful for doctors in explaining the randomisation procedure to an individual patient. The sample comprised 323 patients with cancer attending for out-patient appointments and/or chemotherapy treatment in two major cancer centres in the U.K. 315 patients completed a self-report questionnaire—The Attitudes to Randomised Trials Questionnaire (ARTQ). The results show that the majority of subjects 287 (91.1%) believe that patients should be asked to take part in medical research, but only 242 (76.8%) would be prepared to take part in a study comparing two treatments. If treatment was randomised, only 141 (44.8%) would agree to participate. When given further information about the randomisation procedure, 119 (68.4%) of the 174 (55.2%) who initially said ‘no’ to randomisation or who were unsure, would change their minds and take part in a trial. The ARTQ discriminated between three categories of patient with the following prevailing attitudes: (a) those who seem comfortable with the concept of randomisation; (b) those with some concerns, who with fuller explanation are prepared to consider randomisation; and (c) those firmly against randomisation and participation in trials whatever information is provided. Prior knowledge of patients’ attitudes might assist communication about trials and encourage more doctors to approach eligible patients.

Introduction

Although large numbers of patients are eligible to participate, accrual in clinical trials of cancer therapy is very low[1]. This impedes the introduction and evaluation of new treatments. Recruitment difficulties arise from, and are exacerbated by, a variety of issues, which include the changing pressures on delivery of healthcare[2], concern about ethical and medico-legal issues[3], and attitudes of both patients4, 5and doctors6, 7, 8. Patients may decline entry into randomised clinical trials because of uncertainty about personal benefit[5], concerns as to whether or not the best available treatment would be given (although it has been shown that trial participation leads to better outcomes[9]) and overestimation of the likely therapeutic benefits of standard therapy[10]. Poor understanding about the value of clinical trials specifically, and experiments in medicine in general, produces suspicion and confusion among the general population11, 12.

Considerable ignorance exists about the meaning of randomisation. Many patients are worried about the process, preferring the doctor, whom they trust, to make treatment decisions rather than leaving them to a computer and the play of chance[13]. One study reported that 63% of patients refused entry into a trial because of their aversion to randomisation[5]. Even if a patient does agree to participate in a clinical trial, there is evidence that this consent is not always as informed or educated as it ought to be[14]. Many patients do not even recall that they are receiving experimental treatment15, 16, 17.

There is evidence that most patients are generally altruistic and are willing participants in clinical trials if they are approached. Slevin and colleagues[18]reported that the most important aspects of trial participation, as ranked by patients, were: the likelihood of being treated by a doctor with a specialist interest in cancer, having progress closely monitored and contributing to research knowledge that benefits humanity. When patients were asked if they would take part in a research trial 42% said that they would, 10% said that they would not and 48% were uncertain. This study did not examine the specific question of randomisation.

There has been little study of the differing needs of patients for information, either in its amount or content. Patients can suffer from too much being said, as well as too little19, 20. Whatever a trial protocol may suggest, it is clear that many doctors make intuitive decisions about the disclosure of different sorts of information to individual patients about prognosis and therapeutic benefits expected from different treatment arms. They argue that adapting the information giving is done in the patient’s best interests[21]. Despite the importance of the topic and the contentious debates in the literature22, 23, this whole area is not well-informed by empirical studies. A more rational basis for determining how much and what sort of information needs to be given to an individual patient who is eligible for entry into a clinical trial is required[24]and cancer patients’ preferences for different sorts of information have been published25, 26.

The reluctance of clinicians to enter eligible patients into clinical trials may be a more limiting factor than patient reluctance to participate8, 27, 28. Barriers include practice constraints within the system of healthcare delivery[2], but inadequate training in communication skills contributes to difficulties when explaining randomisation. Giving complex information and obtaining informed consent were acknowledged by 178 senior oncologists attending communication skills courses to be their primary problem areas[29]. Some doctors perceive conflicts between the role of clinician and scientist7, 8and many express anxiety about the impact that the necessary disclosure of uncertainty might have on the doctor–patient relationship6, 8, 27. In a recently published survey of cancer clinicians’ attitudes to clinical trials, a wide range of factors that influenced the willingness of doctors to approach eligible patients were identified. Doctors have idiosyncratic criteria, not only for disclosure of information, but also for deciding who they should approach about trial entry[8].

The present study was carried out to determine the attitudes of cancer patients to the concept of randomisation, and to ascertain whether, for those patients expressing unease, their attitude would be modified after further explanation. The longer term aim was to develop an instrument which might subsequently be useful for doctors in explaining randomisation to an individual patient.