iMATCH
Research type
Research Study
Full title
The use and development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) setting
IRAS ID
302737
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Patients' experience 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 Outcome Measures (PROMs) which collect data on quality of life, symptoms, and experiences from the patient perspective. Despite the increase of interest in Advanced Therapy Medicinal Products (ATMPs) trials, there continues to be a deficiency of including and reporting of Patient Reported Outcomes (PRO) in trials of this new therapeutic area.
The aim of this study is to develop a PROM for use in ATMP trials ensuring that patients centred outcomes are prioritised. Furthermore this work will contribute to the overall understanding, implementation and evaluation of PROMs within ATMP trials. The study will be conducted at a tertiary cancer centre over the following four stages:
Stage I: Two focus groups with 4-6 participants each and approximately 10 interviews will be conducted with ATMP patients to capture their experiences of receiving ATMP including quality of life, symptom experience, adverse events and other relevant themes that may emerge.
Stage II: Following the creation of a draft item list, approximately 5-7 participants from Stage I and 3-5 study naïve patients will undergo cognitive interviews to ensure that all items are clear and easily understood.
Stage III: A draft PROM will be administered to approximately 100 participants receiving ATMP along with the EORTC PATSATC33 and FACT-G questionnaires. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability.
Stage IV: The final PROM will be pilot tested with approximately 10 patients to assess its acceptability.
Eligible patients will be: patients recruited into ATMP trials, able to read and understand English, able to provide informed consent and over 16 years of age.
REC name
London - Queen Square Research Ethics Committee
REC reference
22/LO/0765
Date of REC Opinion
20 Dec 2022
REC opinion
Further Information Favourable Opinion