PREM-ECM
Research type
Research Study
Full title
Development and validation of a patient reported experience measure for experimental cancer medicine (PREM-ECM)
IRAS ID
242539
Contact name
Sally Taylor
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Research Summary:
Patients' experiences of treatment and care is a major indicator of quality and is used as a metric for improvements in healthcare. There has been significant expansion in the development and application of patient reported questionnaires that measure care experiences; Patient Reported Experience Measures (PREM).There is no available PREM for patients taking part in phase 0-2 clinical trials. This study aims to develop and test a PREM in experimental cancer medicine(PREM-ECM) for clinical application.
All patients will be receiving clinical care at The Christie:
Stage I: Two focus groups with 6-8 patients each and 15-20 interviews will be conducted with experimental cancer trial participants to capture their experiences of participating in clinical trials and the care they have received within the trial.
Stage II: From Stage I, potential items for PREM-ECM will be extracted and 5-7 patients who have participated in stage 1 will be asked to attend an interview with the researcher(s) to ensure items are clear and understandable. A further 3-5 study naïve patients will also be asked to participate in this stage.
Stage III: 180 patients will complete a draft PREM-ECM, and the validated EORTC PATSATC33 questionnaire, Patient experience questionnaire and the Hospital Anxiety and Depression Scale. Approximately 50 patients will be asked to repeat completion of the PREM-ECM approximately one week later to assess change over time.
Stage IV: Pilot testing of the PREM-ECM will be conducted with 20 patients to assess its feasibility for routine collection of patient experience data.
Eligible patients will be: patients recruited into phase 0-2 experimental cancer medicine clinical trials, able to read and understand English, able to provide informed consent and over 18 years of age.Summary of Results:
Over the last few years, the Christie Patient Centred Research team have been carrying out a study to develop and test a questionnaire to record the experiences of patients taking part in experimental cancer medicine clinical trials and their carers (friends/family). This type of questionnaire is called a patient report experience measure (PREM). We have completed the study and the results have been published in an academic journal.
Four main topics were discussed in patient interviews, these were information needs, decision-making, experience of trial participation, and impact of trial participation. During the interviews participants suggested the need for three separate questionnaires:
‘Prior’ captures patients experiences of trial introduction, screening, consenting, and early trial experience, to be completed up to 6 weeks post consent.
‘On trial’ captures patients experiences of ongoing consent and trial participation and was completed anytime after 6 weeks into their trial treatment.
‘Carer’ captures experiences of carers of patients on an experimental cancer medicine trial.
We used the topics from the interviews to develop questions and then tested them with patients and carers to make sure they were relevant and easy to understand. After making any changes needed, 162 patients completed the two patient questionnaires and 102 carers completed the carer questionnaire. We then used the data collected to help us reduce the number of questions (items) in the questionnaires to ensure it was useful but not too long. We produced a final 14-item ‘prior’, 15-item ‘on-trial’ and 13-item carer questionnaire. The three questionnaires developed in this study will be used in future trials and in clinical practice.REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0299
Date of REC Opinion
19 Jun 2018
REC opinion
Further Information Favourable Opinion