Immunotherapy related Adverse Events -The Patient Experience (v1)
Research type
Research Study
Full title
Patients' experiences of immune related adverse events when receiving immunotherapy
IRAS ID
245995
Contact name
Martin Forster
Contact email
Sponsor organisation
University College London Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Immunotherapy has revolutionised the treatment of many cancers by allowing the immune system to fight cancer cells. However, it causes adverse effects which must be managed promptly and appropriately.
The aims of this study are to describe the types of adverse drug events experienced by patients who have received immunotherapy (Part 1 audit) and individual patient experiences of adverse drug events in terms of their management and impact (Part 2 interviews).
For part 1, patients will be identified through the chemotherapy electronic prescribing records of University College London Hospital (UCLH) pharmacy. Case-notes and electronic records will be reviewed to identify patients who have experienced an adverse drug event(s) over the previous six months. It will document details of treatment and the healthcare management of the immune-related adverse event (Ir-AE) using a data extraction form. Patients will be followed up via the records from the date of start of immunotherapy treatment to the experience of any Ir–AEs and their management. Baseline clinical details of all patients who received immunotherapy will be collected: age, gender, concurrent medications, and other health conditions. Case-notes will confirm the stage of disease and grade of adverse event, type of Ir-AE, treatments of Ir-AE and outcomes.
Face-to-face (or telephone) semi-structured interviews will be conducted with patients, some of whom will have experienced an adverse event and some who will not have reported any adverse events to provide information on the nature and severity of the adverse events and to obtain their views of Ir-AE pathways and barriers and facilitators to reporting and receiving prompt treatment for them.
This knowledge will help us to understand the adverse events experienced by patients on immunotherapy as well as their management and impact and ultimately improve the pathways of care and support.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0233
Date of REC Opinion
29 Aug 2018
REC opinion
Further Information Favourable Opinion