Patients experience of taking part in a breast cancer clinical trial
Research type
Research Study
Full title
Patients experience of taking part in a placebo-controlled and double-blind clinical trial in breast cancer
IRAS ID
179840
Contact name
Debbie Carrick-Sen
Contact email
Sponsor organisation
The University of Birmingham
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Double-blind and placebo-controlled clinical trials are required to determine if a new cancer drug is effective. In these trials patients receive a new experimental or the current best available drug. In a double-blind trial, the patient and clinician do not know which drug they are taking. If there is no current best drug available, the experimental drug will be compared with an ‘inert’ drug called a ‘placebo’. Patients’ experience of taking part in this type of clinical trial is relatively understudied. Current literature often examines the consent process and information giving with a view to increasing recruitment into clinical trials rather than studying the experience of patients. This study uses a qualitative method to explore the experience of patients with breast cancer who have participated in a double-blind placebo-controlled trial. Face to face, semi-structured interviews will be carried out in a single centre (Nottingham University Hospitals NHS Trust) with a sample of up to 10 participants. An iterative approach will be taken in this study; data will be analysed following each interview. This will be used to adapt and improve on the interview questions used for the subsequent participant. Transcripts of the interview will be made in full verbatim by the researcher to enable further familiarisation and they will also include all verbal and non-verbal cues in order to obtain a full picture of meaning from the participant. The analytical framework for the data will be Thematic Analysis using Braun and Clarke (2006) framework. Participation in these types of clinical trials is important to enable the development of new medicines, however understanding the patient experience is important and under-researched. It is important for clinicians and clinical research nurses to understand the experience in order to ensure appropriate care and advice is provided.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0028
Date of REC Opinion
8 Feb 2017
REC opinion
Favourable Opinion