PROM OSP
Research type
Research Study
Full title
Development of a patient reported outcome measure for advanced ovarian cancer patients receiving surgical and chemotherapy treatment
IRAS ID
304794
Contact name
Sally Taylor
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Duration of Study in the UK
0 years, 2 months, 29 days
Research summary
In recent years 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.
This study aims to develop the first PROM that measures the impact of combined surgery and chemotherapy on ovarian cancer patients' quality of life (QOL).
Stage I – Item generation
Approximately 20 interviews will be conducted in person or via telephone with ovarian patients receiving combined surgery and chemotherapy to capture their experiences including QOL, symptom experience, and other relevant themes that may emerge. The interviews will be audio recorded and transcribed verbatim. Data will be analysed thematically and key quotes extracted which will be used to create a draft item list. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.Stage II – Cognitive interviewing
Following the initial interviews, approximately 7 participants will undergo cognitive interviews, in person or via telephone to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.Stage III – Item reduction and refinement of the draft PROM
A draft PROM and the EORTC QLQ-C30 will be administered in person or via post, to approximately 100 ovarian cancer participants receiving combined surgery and chemotherapy. Approximately 50 patients will be asked to repeat the draft PROM approximately one week later to assess test-retest reliability. Hierarchical item reduction and Rasch analysis will be used to determine which items should be included in the final PROM.Stage IV– Pilot testing
The final PROM will be pilot tested with approximately 10 patients to assess its acceptability, in person or via post.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0074
Date of REC Opinion
16 Feb 2022
REC opinion
Further Information Favourable Opinion