The decision to participate in phase I cancer clinical trials can be complex. Prior studies have suggested that some patients on early phase trials may not fully appreciate the purpose, risks and low chance of benefit. Question Prompt Lists (QPL) have proven benefit in studies across different medical specialties in empowering the patient to participate in their consultation. Although there is literature assessing the value of QPLs in cancer clinical trials, it has not been explored specifically in the phase I setting. This single centre qualitative study has described the patient’s experience of using a customised phase I QPL.
A phase I specific QPL was designed with patients using an experience based co-design process. Following this, 13 patients were given the QPL to use in their consent consultation. Semi structured interviews were conducted, recorded, transcribed verbatim and analyzed using Colaizzi’s (1978) descriptive phenomenology. The questions explored the patients’ experience during the consent consultation; how patients used the QPL, what value was placed on it and why it wasn’t used.
Between July-September 2020, 13 patients were interviewed; age range 38-73; 7 male, 6 female. Five themes emerged: 1. Emotions expressed 2. Benefits of the QPL 3. Questions asked 4. Barriers to using the QPL 5. Future recommendations Described emotions included; vulnerability, fear, desperation and hope of trial success. Patients felt the QPL improved their participation, reminded patients what questions they wanted to ask and triggered questions not previously thought of. Barriers to using the QPL included; time pressures, fear of being judged and avoidance of distressing conversations. All 13 patients recommended using a QPL.
A QPL is a simple tool that has the potential to improve the patient’s ability to ask the questions that are important to them. Patients that used the QPL felt that their confidence was bolstered to articulate concerns. As early phase trials increase in complexity, better and earlier orientation to the QPL could address the described barriers of its use. Therefore a QPL has the potential to enhance the informed consent process for the patient.
Clinical trial identification
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Has not received any funding.
All authors have declared no conflicts of interest.