QLQ-C30 Validation
Research type
Research Study
Full title
Validation of the EORTC QLQ-C30 with young people aged 12-17 years with cancer
IRAS ID
250956
Contact name
Anne-Sophie Darlington
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The European Organisation for Research and Treatment of Cancer Quality of Life Group Core measure (EORTC QLQ-C30) is the most widely used cancer health-related quality of life (HRQoL) questionnaire. We will be recruiting adolescents (12-17 years) (n=300 minimum) who have been diagnosed with cancer and receiving treatment for curative intent or who are receiving palliative care. We would like to know whether the EORTC QLQ-C30 is acceptable, and if the content is relevant and representative for this age group. We will also be comparing young people and their parents'/ guardians' questionnaire responses.
This current study has a target sample size of 300. There will be a good spread of participants according to language, culture (this is an international study), age sub-group (12-14 years and 15-17 years), on treatment and palliative care. For pragmatic reasons, we envisage recruiting fewer patients receiving palliative care compared with those on treatment with curative intent.
Participants will be asked to complete the EORTC QLQ-C30 followed by a debrief interview asking about their experience of completing the questionnaire. They will also be asked to complete the 23 item PedsQL teen self-report form designed for adolescents aged 13-18 years. This measures physical, emotional, social and school (role) functioning thus it lends itself for comparison with the EORTC QLQ-C30. The young people will also be invited to complete a 15-item symptom checklist. Socio-demographic and clinical characteristics including the ECOG performance status will be completed. Participants will be recruited by a member of the research or clinical team while visiting the hospital as an inpatient or outpatient or they will be contacted by their clinician. Questionnaire completion will be carried out at the hospital, over the telephone, Microsoft Teams or at the participant’s home.
Lay summary of study results: Background Having a diagnosis of cancer at any age can be traumatic and affect different aspects of life. For adolescents who are going through many life changes a cancer diagnosis is likely to be even more disruptive compared to younger children or older adults . Scientists developing new medicines for cancer need to take into consideration the impact on quality of life when carrying out tests of these treatments during clinical trials. The EORTC QLQ-C30 is a Quality of Life questionnaire designed for adults with cancer and is the most widely used cancer quality of life measure, playing an important role in outcome assessments for clinical trials. However, adolescents with cancer are often not included in clinical trials, and there are efforts to improve their involvement. The current study evaluates whether the EORTC QLQ-C30 is acceptable and useful for this age group and provides us with information to encourage the use of the questionnaire in clinical trials with adolescents.
Methods
Adolescents aged 12-17 years with cancer completed the EORTC QLQ-C30 alongside a questionnaire designed for young people called the PedsQL Cancer Teen. Participants were also asked about what they liked and disliked about the questionnaires, which one they preferred and whether they would rather complete questionnaires on paper or online.Results
A total of 200 adolescents, average age 14 1/2 years, 51.5% males, were involved in this study and came from 10 countries. Blood cancers were the most common (48%) and 91% adolescents had received chemotherapy. The EORTC QLQ-C30 took on average 12 minutes to complete. Adolescents referred to the questionnaire as helpful, “not too boring” and easy to complete. Only eight participants identified an upsetting or inappropriate question and the question about financial difficulties was the most frequently mentioned as irrelevant due to their age. The need for more age-appropriate questions was also recommended by 25% participants. While over half adolescents preferred the PedsQL, 29% preferred the QLQ-C30 and 57% said that they felt more comfortable completing the questionnaire on paper rather than electronically.Conclusions
The EORTC QLQ-C30 shows potential as a valuable questionnaire which can be used with adolescents, as well as adults, in clinical trials. For more information, please click on this link: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fqol.eortc.org%252Fquestionnaire%252Faya%252F%2FNBTI%2FuoS8AQ%2FAQ%2Fe2cfe286-d837-4863-8598-f14c4648e724%2F1%2FrI4DQ74kRZ&data=05%7C02%7Cbloomsbury.rec%40hra.nhs.uk%7Cc6637e7f765b4eceb9d308dd75d1994e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638796265264205328%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=fNAQDsWRAZkusg6o5i1Nt7jGcEoRRbKtfhMTfb3zKDk%3D&reserved=0REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/PR/0170
Date of REC Opinion
28 Sep 2020
REC opinion
Further Information Favourable Opinion