Many questionnaires have been developed to help provide patients with an opportunity to accurately report their own experiences during and after receiving treatment. These questionnaires are called Patient Reported Outcome Measures (PROMs) and help to provide a greater understanding of the impact of a disease and/or how it is treated. By using PROMs we hope to better understand what matters to patients in terms of symptom experience and management during and after complex cancer treatments.
Recent literature has suggested that PROMs are not used as often in Advanced Therapy Medicinal Product (ATMP) patients as they are in other patient groups; perhaps due, in part, to the lack of a questionnaires specific to this group of patients. The purpose of this study is to develop a specific PROM questionnaire for patients receiving Adoptive Cell Therapy (a type of ATMP) in a cancer setting. We aim to create a tool that will allow us to assess quality of life and characteristic symptoms of patients across different stages of the treatment pathway, and to develop guidelines for the use of PROMs in this setting to ensure that the experiences of patients receiving these treatments are captured and used to improve future delivery of ATMPs.
The project is split into 4 stages:
- Stage I – We will use interviews with patients to develop a list of key themes regarding patient experiences.
- Stage II – The data collected in Stage I will be used to create possible questionnaire items. A second round of interviews will be conducted where patients will be asked if the potential questions we have created address their experiences and are clear and easy to understand.
- Stage III – A draft PROM will be completed by patients receiving Adoptive Cell Therapy and reliability will be assessed.
- Stage IV – Pilot testing will be completed in a clinic setting to assess acceptability.
The first patient was recruited at The Christie NHS Foundation Trust (Sponsor and site conducting the research) in May 2023 and the study aims to complete mid-2024. To find out more, please visit clinicaltrials.gov (NCT05721365) – The Use and Development of Patient Reported Outcome Measures (PROMs) in the Adoptive Cell Therapy (ACT) Setting – Full Text View – ClinicalTrials.gov
This work is funded by GSK as part of an Investigator Sponsored Study.