Use of a Question Prompt List in the phase I clinical trial setting.
Research type
Research Study
Full title
The experience of using a Question Prompt List (QPL) within an Oncology Phase I Clinical trial setting.
IRAS ID
274740
Contact name
Sarah Stapleton
Contact email
Sponsor organisation
The Royal Marsden Hospital
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
A question Prompt List (QPL) is a list of questions that patients may want to ask during their consultation with a doctor. QPLs have shown to have benefit across different medical specialties in empowering the patient to participate in their consultation. Although there is literature assessing the value of QPLs in the oncology clinical trial setting (Tattershall 2018), it has not been explored in the phase I trial setting.
The Oncology Phase I clinical trial patient group have usually exhausted known proven treatments available to them on the NHS. They have an advanced terminal cancer, however remain clinically well, therefore some patients opt to participate in an early phase trial with little efficacy data and risks of drug toxicity. The literature suggests that some phase I trial patients do not fully understand the purpose, risks and low chance of benefit of their trial & expectations are unrealistically high (Pentz 2012).
Research Question: What is the experience of using a Question Prompt List (QPL) within an Oncology Phase I Clinical trial setting?
The aim of this study is to introduce and use a phase I specific QPL for the patient to use during their consent consultation and understand their experience of it.
It is an exploratory, qualitative study using semi structured interviews with up to 13 patients and 1 group interview with the medical team involved in consenting patients that have been exposed to the QPL to explore their experience.
The patient sample will be recruited from the researcher’s Drug Development Unit (DDU), all new patients that are offered a phase I trial are eligible.
The patient will be asked to participate in one 45 minute 1-1 semi structured interview that will be recorded, transcribed and analyzed using thematic analysis adopting a phenomenological approach.REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0025
Date of REC Opinion
4 Mar 2020
REC opinion
Further Information Favourable Opinion