Quality of life in paediatric sarcoma
Research type
Research Study
Full title
Development of a paediatric version of the Sarcoma Assessment Measure (SAM-Paeds): a specific tool for assessing quality of life in children with sarcoma.
IRAS ID
264472
Contact name
Madeleine Adams
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The aim of this study is to develop a disease-specific quality of life (QoL) measure for children undergoing treatment for sarcoma. The Sarcoma Assessment Measure: Paediatric Version (SAM-Paeds) will be developed as an addition to the SAM tool which has already been designed for adults with sarcoma. There are currently very few studies of QoL during treatment for sarcoma in childhood and those that have been carried out use generic tools which are often not sensitive enough to the specific issues related to sarcoma. The new international clinical trial for rhabdomyosarcoma (FaR-RMS) will measure QoL between the different radiotherapy randomisations and in order to identify differences it is vital that a sensitive tool is used. Once developed SAM-Paeds will be entered into the Far-RMS study to better understand QoL for patients during treatment and whether there is any difference in QoL scores between pre and post-operative radiotherapy.
The methodology comprises four stages; item generation which involves focus groups and structured interviewing, item reduction, questionnaire formatting and psychometric testing of the questionnaire. Face and content validity testing will be carried out as well as reliability testing of the final version.
Patients, parents and healthcare professionals looking after children with sarcoma will be involved in all stages of questionnaire development to ensure that all relevant issues are included within the questionnaire. The final version will be used either as a standalone measure or alongside generic QoL tools to increase understanding of QoL during treatment for sarcoma and allow interventions to improve QoL for patients and their families. The final version will be available for use in clinical consultations as well as research studies to identify areas where patients require support.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0511
Date of REC Opinion
27 Nov 2019
REC opinion
Further Information Favourable Opinion