Abstract
BackgroundClinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging.AimTo gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved.MethodsIn-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process.Results‘Nothing to lose’ was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the ‘only hope in the room’. The decision regarding participation was taken within a ‘trusting relationship’ that was important to both patients and professionals. Both were united in their ‘fight against cancer’. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model.ConclusionThis study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.
Highlights
Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible
It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process
This study aims to address this gap in our knowledge of the consent process through the use of in-depth interviews, with both cancer patients who had been offered participation in a clinical trail and healthcare professionals who were involved in the consent/recruitment process
Summary
Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. All clinical research is contingent on informed consent [1,2,3]; which provides potential research participants with sufficient information, including anticipated benefits and potential risks of the study and any discomfort it may entail This process is crucial, allowing patients to make a voluntary and autonomous decision as to whether participation is right for them [4]. The patients’ state of mind may be a factor, with some sources asserting patients in this situation are often motivated by hope of personal medical benefit [15,16,17], holding overly optimistic expectations of this benefit [18] This has raised concerns of ‘therapeutic misconception’ [19], whilst others argue it is “therapeutic optimism” [20,21,22]. It is hugely challenging to square off these differing perspectives; the absence of an established evidence base in many areas of palliative care medicine has been partially attributed to the ethical challenges inherent in research within this population - including problems with consent [24]
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