Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Samantha Sodergren
Principal Investigator
Faculty of Health Sciences, University of Southampton
Southampton, United Kingdom
, David Riedl
Principal Investigator
Medical University of Innsbruck
Innsbruck, Austria
Study coordinator(s)
Maria Rothmund
Principal Investigator
Medical University of Innsbruck
Innsbruck, Austria

Project summary

Care for childhood cancer(s) has greatly improved over the last decades exceeding 85% 5-year survival in countries with optimal health-care resources (1-4). Although treatment regimens are optimized to reduce unpleasant side effects, many paediatric cancer patients still experience significantly decreased physical, mental, emotional, and social health due to their disease and its treatment (5-6). Thus, the assessment of health-related quality of life (HRQOL) is a critical outcome measure for anti-cancer treatment in children. Research has shown that, by the age of 8 years, children are capable to give reliable and valid self-reports on their. However, questionnaires have to be age-specific and developed in accordance with the child’s developmental stage (7).

While several questionnaires have been developed to assess the health-related quality of life (HRQoL) in children with cancer, recent research has highlighted several issues in terms of content validity and questionnaire development (8-9).

The current study is designed to capture the HRQoL issues relevant and important to children with cancer. This study will also provide an evaluation of optimal response formats for children aged 8-14 years and from this will offer recommendations to the EORTC Quality of Life group (QLG) on a suitable HRQoL assessment approach for this age group.


1.      International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol. 2017;18(6):719-31.

2.      Gatta G, Botta L, Rossi S, Aareleid T, Bielska-Lasota M, Clavel J, et al. Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5–a population-based study. Lancet Oncol. 2014;15(1):35-47.

3.      Siegel DA, King J, Tai E, Buchanan N, Ajani UA, Li J. Cancer incidence rates and trends among children and adolescents in the United States, 2001-2009. Pediatrics. 2014;134(4):e945-55.

4.      Smith MA, Altekruse SF, Adamson PC, Reaman GH, Seibel NL. Declining childhood and adolescent cancer mortality. Cancer. 2014;120(16):2497-506.

5.      Ruland, C.M., Hamilton, G. A., & Schjødt-Osmo, B. (2009). The complexity of symptoms and problems experienced in children with cancer: A review of the literature. Journal of Pain and Symptom Management, 37(3), 403–418.

6.      Kestler, S.A.,&LoBiondo-Wood,G. (2012). Review of symptom experiences in children and adolescents with cancer. Cancer Nursing, 35(2), E31–E49.

7.      Matza, L. S., Patrick, D. L., Riley, A.W., Alexander, J. J., Rajmil, L., Pleil, A.M., & Bullinger,M. (2013). Pediatric patient-reported outcome instruments for research to support medical product labeling: Report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value in health, 16(4), 461–479.

8.      Anthony SJ, Selkirk E, Sung L, Klaassen RJ, Dix D and Klassen AF. Quality of life of pediatric oncology patients: Do patient-reported outcome instruments measure what matters to patients? Qual Life Res 2017;26:273-281.

9.      Pinheiro LC, McFatrich M, Lucas N, Walker JS, Withycombe JS, Hinds PS, et al. Child and adolescent self-report symptom measurement in pediatric oncology research: a systematic literature review. Qual Life Res 2018;27:291-319.


  • Two reviews on use of patient-reported outcome measures in clinical trials on anti-cancer treatments and supportive interventions for children with cancer
  • Literature review on health-related quality of life issues in children with cancer is under review
  • First and second round of interviews ongoing

Current status:

Phase 1a, recruitment ongoing

Phase 1b, recruitment ongoing

Future plans

We submitted a proposal to extend our work on younger children up to 8 years, which is currently under review by the EORTC QLG. In this way, we aim to complement the portfolio of EORTC QLG measures to cover the whole spectrum of ages.



For further information about the study or to express an interest in collaboration, please contact:

David Riedl
Samantha Sodergren

For patients

Treatment for children with cancer has improved greatly over the last decades. Thus, it is important to find out how these effective treatments affect the children’s physical and mental well-being too. A good way to find this out is to use questionnaires. Although several questionnaires have been specifically developed for children with cancer, some researchers are unsure if they include all important aspects. Thus, we have looked at existing questionnaires and studies to find out if they include all aspects that have found to be important to children with cancer. Additionally, we talk with children with cancer, their parents and their doctors to find out if there is anything we might not have covered so far.


Riedl, D. & Rothmund, M.S., Darlington, A.S., Sodergren, S., Crazzolara, R., de Rojas, T. on behalf of the EORTC Quality of Life Group (2021). Rare use of Patient Reported Outcomes (PROs) in childhood cancer clinical trials – a systematic review of clinical trial registries. Eur J Cancer, 152: 90-99. doi: 10.1016/j.ejca.2021.04.023. PMID: 34090144.

Rothmund M, Lehmann J, Moser W, de Rojas T, Sodergren SC, Darlington AS, Riedl D (2022). Patient-reported outcomes are under-utilised in evaluating supportive therapies in paediatric oncology – A systematic review of clinical trial registries. Crit Rev Oncol Hematol, 176:103755. doi: 10.1016/j.critrevonc.2022.103755. Epub 2022 Jul 5. PMID: 35803454.

conference abstracts 2021:

Rothmund, M., Riedl, D., Darlington, A.-S., Sodergren, S., Crazzolara, R., & Rojas, T. de (2021). (105.3) An honest look in the mirror: patient-reported outcome measurements are rarely used in pediatric cancer clinical trials: A systematic review of clinical trial registries. Quality of Life Research, 30, S24. (oral presentation at ISOQOL 2021).

Rothmund, M., Riedl, D., Darlington, A.-S., Sodergren, S., Crazzolara, R., & Rojas, T. de (2021). O0201 / #483 An Honest Look in the Mirror: Patient-Reported Outcome Measurements are Rarely Used in Paediatric Cancer Clinical Trials: A Systematic Review of Clinical Trial Registries. Pediatric Blood & Cancer, 68(S5), S101. (oral presentation at SIOP-congress 2021).

Rothmund, M., Rohde, G., Rojas, T. de, Majorana, A., Sodergren, S., & Riedl, D. (2021). O0236 / #520 What Matters to Children with Cancer: A Systematic Review of Qualitative Studies and Patient-Reported Outcome Measures (PROMs). Pediatric Blood & Cancer, 68(S5), S119. (oral presentation at SIOP-congress 2021).

Rothmund, M., Sodergren, S., Rohde, G., Rojas, T. de, Paratico, G., Albini, G., Majorana, A., Darlington, A.-S., & Riedl, D. (2021). (3083) What matters to children with cancer: A systematic review of qualitative studies and patient-reported outcome measures (PROMs). Quality of Life Research, 30, S123. (poster presentation at ISOQOL 2021)