Communication tools for patient-reported outcome findings from cancer
Research type
Research Study
Full title
SISAQOL-IMI WP4:Communication tools for patient-reported outcome findings from cancer clinical trials – qualitative interviews
IRAS ID
298418
Contact name
Galina Velikova
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Rationale: Patient-reported outcomes and health-related quality of life data is increasingly collected in cancer clinical trials (CCTs). Robust international consensus needs to be reached for establishing standards on the design, analysis, presentation, and visualisation of this data in order to meet the needs of a range of stakeholders, including patients. This study seeks to develop guidelines on the visual presentation of such data.
Objective: To investigate the needs, preferences and interpretational accuracy of a range of stakeholders about the presentation of data. Outcomes will inform recommendations to support the development of meaningful data visualisations for reporting patient-reported outcome data from CCTs.
Study design: Qualitative interview study
Study population: Adult (≥18 years) patients who are aware of their cancer diagnosis and treatment plan, healthcare professionals providing cancer care, and stakeholders including patient representatives, policy or administrative decision makers associated with CCTs.
Collaborating centres: This ethics application is for UK site at Leeds Teaching Hospital Trust. The University of Leeds is acting as sponsor for the UK arm of the study. The study is international, led by University of Innsbruck, Austria and has one other collaborating organisation in Spain. Each centre is responsible for ensuring the required ethical approvals are in place before commencing the study.
Intervention: Not applicable.
Main study parameters/endpoints: Topics covered in interviews will include experiences of providing data to or using data from CCTs; barriers and facilitators to using trial data; which information from clinical trials is most important, preferences and needs in relation to visual presentation of data and the accuracy of understanding and interpretation of examples.
Length of the study: Participants will be asked to participate in one audio-recorded interview. The study will run for two years between 1/1/2021 - 31/12/2022, and recruitment will start once approvals have been gained from NHS/HRA ethical review processes.REC name
Wales REC 7
REC reference
21/WA/0279
Date of REC Opinion
26 Aug 2021
REC opinion
Favourable Opinion