This expert commentary discusses the development of the EORTC QLQ-AYA30 – the first international health-related quality-of-life questionnaire designed specifically for adolescents and young adults with cancer, created in response to the lack of age-appropriate tools capturing the unique challenges faced by this patient group.

Adolescents and young adults (AYAs) with cancer face complex and unique challenges by virtue of their developmental stage, the biology of their cancer and their care experiences.

Back in 2013, a session convened at the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) biannual meeting explored the feasibility of developing a health-related quality-of-life (HRQoL) measure for this specific patient group.

At that time, the HRQoL measures within EORTC’s portfolio had been developed for adults aged 18 years or older with cancer. Because they had not been tested in adolescents and had limited representation of the epidemiology of cancer in AYAs, they could not be considered valid for this patient group.

In addition, initial scoping of the literature on measures for AYAs revealed that the options were limited to non-AYA-specific tools, adaptations of adult or paediatric measures by clinicians or researchers that were not necessarily tested with AYAs, or measures that did not cover the full AYA age spectrum.

Given the strong emphasis on HRQoL as a key endpoint in clinical trials,1 alongside the increasing effort to include AYAs as trial participants,2 it became clear that HRQoL measures for this group needed to be specifically designed to address their distinct concerns and capture the outcomes most meaningful to them.

By 2015, funding had been secured for an initial feasibility project to assess the need for a dedicated HRQoL module for AYAs with cancer aged 14–39 years.

Findings from our systematic review3 and in-depth qualitative interviews with AYAs and healthcare professionals,4,5 provided further compelling evidence that the HRQoL experiences of this population are distinct and insufficiently captured by existing measures.

Defining the age range for AYAs

A lack of an agreed definition of the age range for AYAs was also recognised in our systematic literature review.3 At the start of our feasibility work (Phase 1), we defined AYAs as 14–25 years of age at the time of diagnosis, consistent with current local service provision for this age group.

We also conducted age comparisons of HRQoL experiences to examine whether the issues experienced were unique to AYAs aged 14-25 years, or whether there was an overlap with adults outside of this age range up to 39 years.

Shared experiences and challenges were identified, such as achieving autonomy from parents, interruptions to career plans and an impact on romantic relationships.

In addition, to align with international definitions of AYAs as aged between 15 and 39 years6 at the time of cancer diagnosis, the upper age threshold was increased to 39 years while keeping the lower age as 14 years.

From initial concept to final QLQ-AYA30

Our work focuses on AYAs currently receiving treatment or who have completed treatment within the last year and those receiving palliative care, rather than on cancer survivors, as defined by the EORTC QLG.7

The EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) is the most widely used HRQoL measure. 8–11

The EORTC QLG adopts a modular strategy12 for the development and international validation of measures to supplement the QLQ-C30, and this process was rigorously carried out across four phases to develop the EORTC QLQ for Adolescents and Young Adults with Cancer 30 (QLQ-AYA30).

This is the world’s first comprehensive measure of HRQoL, developed for and with AYAs with cancer aged 14–39 years.13

QLQ-AYA30 is a 30-item questionnaire comprising five multi-item subscales: activity limitations and life disruptions, worry about cancer and the future, self-esteem, relationships and positive changes, as well as nine single items.

It is currently available in 17 languages, with seven additional language versions in preparation.

Insight from patients and HCPs

According to the ethos of the EORTC QLG, AYAs are at the heart of our work as participants and research partners, from issue generation to question testing and feedback, ensuring that the questions measure important and relevant aspects of HRQoL without significant omissions.

Healthcare professionals (HCPs) with expertise in treating AYAs with cancer also participated in our studies and, alongside young people research partners, have been involved in expert consensus meetings where decisions about the questionnaire content were made.

A total of 365 AYAs and 28 HCPs from 20 countries worldwide were involved in the first three phases of its development.

During Phase 1, a total of 87 issues relevant and important to AYAs with cancer were identified through a literature review and in-depth, semi-structured interviews with AYAs and HCPs.

These issues were then further reviewed for relevance, overlap and redundancy, resulting in the operationalisation of 50 questionnaire items during Phase 2.

Of the questions included in the draft questionnaire, 10 were drawn from the EORTC QLG’s library of items already included in existing QLG measures, 14 were adapted from items in the library and 26 were new.

Robust psychometric properties

Phase 3 pilot testing of the QLQ-AYA30 with 253 AYAs from 19 countries provided preliminary support for its reliability, validity and cross-cultural acceptability. In brief, there was no evidence of floor or ceiling effects for the items, and the scores showed a good range.

A fix-factor solution was favoured from the exploratory factor analysis, and internal reliability of items within these sub-scales (domains) ranged from moderate–acceptable (relationships: Cronbach’s alpha = 0.659) to acceptable (positive changes: Cronbach’s alpha = 0.770).

Following rigorous review by the EORTC QLG, the QLQ-AYA30 is now available for use in clinical practice and trials and is available on request.

However, this is subject to the caveat that further, more extensive testing of the questionnaire as part of its Phase 4 international validation might result in changes to the scale structure and, therefore, to questionnaire scoring.

Unique HRQoL needs for AYAs identified

Questions within the positive changes domain were rated as the most relevant to AYAs during Phase 3 testing, particularly those relating to reassigning life priorities to distinguish between important and unimportant things (89%) and to improved motivation to live life to the full (84%). These questions are largely absent from other EORTC QLG measures.

Questions relating to body image and fertility were also highlighted by AYAs as particularly important, with 24% nominating them as priority questions. This supports evidence from the literature on common concerns for this age group.3

Other notable questions of importance to AYAs included lack of energy and concerns about future health, which are not necessarily unique to this age group.

Multidisciplinary collaboration to support HRQoL

To date, the development of the QLQ-AYA30 has involved collaboration among 43 researchers and clinicians from diverse professional backgrounds, including surgery, nursing, medical and clinical oncology, psychology, epidemiology, sociology, pharmacy and statistics.

During the phase 1 work, collaborators and HCP participants complemented the perspectives shared by AYAs, whose expertise stems from their lived experience, with each discipline contributing unique expertise.

For example, oncologists and surgeons helped to identify treatment-related concerns such as symptom burden and long-term side effects.

Psychologists highlighted emotional wellbeing, identity development and coping mechanisms, while nurses and sociologists contributed perspectives on day-to-day functioning, relationships, education, employment and support needs.

Statisticians and epidemiologists ensured methodological rigour, psychometric validity and cross-cultural applicability.

This multidisciplinary approach is especially important in AYA cancer care because these individuals occupy a distinct developmental stage between childhood and older adulthood.

Cancer can disrupt education, career development, fertility, body image, independence, peer relationships and family roles in ways not typically captured by paediatric or adult cancer measures.

Care of AYAs therefore extends beyond disease management alone, requiring coordinated input from medical, psychosocial and support services.

By incorporating perspectives from multiple disciplines and countries, the QLQ-AYA30 better reflects the multidimensional nature of AYA cancer experiences across diverse healthcare systems and cultural contexts, thereby supporting more holistic assessment and person-centred care.

Further validation of the QLQ-AYA30

A Phase 4 study is currently in set-up and will involve between 450 and 500 AYAs who will complete the QLQ-AYA30 alongside the QLQ-C30, as well as additional feedback questions.

The analysis plan for this phase involves more extensive psychometric testing of the scale’s structure. This will include confirmatory factor analysis; item response theory analyses; differential item functioning; and tests of discriminant and convergent validity, reliability (internal and test-retest), responsiveness to change and known-group validity.

Only after this phase is complete can the QLQ-AYA30 be presented as a valid measure of HRQoL for AYAs.

Looking to the future of HRQoL

Routine use of the QLQ-AYA30 has the potential to substantially reshape how clinicians engage with AYAs with cancer. It systematically captures issues that are often overlooked in standard oncology consultations, such as fertility concerns, body image, autonomy, relationships, education/work disruption and future uncertainty, as well as positive changes.

It also has the potential to track changes over time and trigger supportive care where needed. Its use in clinical practice could make consultations more patient-led and holistic.

Beyond focusing on treatment toxicity and disease response, the QLQ-AYA30 would also provide insight into psychosocial and developmental concerns.

By surfacing these concerns early, the questionnaire can serve as a conversation starter, normalise difficult topics and support more meaningful dialogue between AYAs and multidisciplinary teams.

Repeated administration of the questionnaire over time would also enable clinicians to monitor symptom burden and shifting priorities throughout the treatment trajectory – from diagnosis through active treatment into survivorship or palliative care. This longitudinal approach is particularly valuable in AYA oncology, where needs evolve rapidly alongside developmental milestones.

The tool may also strengthen shared decision-making by giving AYAs a clearer voice in treatment discussions. When clinicians can explicitly see how treatment is affecting domains important to the patient, decisions can better reflect personal values and life goals.

In the context of clinical trials, integrating the QLQ-AYA30 could help to standardise AYA-specific HRQoL assessment, addressing a major gap in oncology research, where AYA trials have historically under-used patient-reported outcomes as endpoints.14

Standardised use would improve comparability across studies, strengthen evidence on treatment effects beyond survival, and help establish quality-of-life outcomes as core endpoints in AYA oncology trials. It may also inform regulatory and policy decisions on interventions and supportive care models.

However, for successful routine integration, it is not enough to just introduce the questionnaire. Important factors include embedding it into busy healthcare environments, ensuring the accessibility and clarity of the questionnaire data, making the questionnaire acceptable and manageable for both patients and clinicians, and providing suitable support services to address issues uncovered during screening.

This research was funded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group, grant number [002-2018]. The EORTC QLG business model involves license fees for commercial use of their instruments. Academic use of EORTC instruments is free of charge.

Authors

Dr Samantha Sodergren PhD
Senior research fellow, University of Southampton, UK

Professor Anne-Sophie Darlington PhD
EORTC QLQ-AYA30 chief investigator
Professor of child and family psychological health, University of Southampton, UK

Professor Dan Stark MD PhD
Professor of teenage and young adult cancer research, University of Leeds, and honorary consultant medical oncologist, Leeds Teaching Hospitals NHS Trust, UK

References

  1. US Food and Drug Administration. Core Patient-Reported Outcomes in Cancer Clinical Trials: Guidance for Industry. Silver Spring, MD: FDA; 2024.
  2. Sankaran H et al. Enrollment of adolescent and young adult patients newly diagnosed with cancer in NCI CTEP-sponsored clinical trials before and after launch of the NCI National Clinical Trials Network. Cancer 2022;128(21):3843–9.
  3. Sodergren SC et al; EORTC Quality of Life Group. Systematic review of the health-related quality of life issues facing adolescents and young adults with cancer. Qual Life Res 2017 Jul;26(7):1659–72.
  4. Sodergren SC et al. A Life Put on Pause: An Exploration of the Health-Related Quality of Life Issues Relevant to Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol 2018 Aug;7(4):453–64. Erratum in: J Adolesc Young Adult Oncol 2019 Feb;8(1):103.
  5. Sodergren SC et al; EORTC Quality of Life Group. Does age matter? A comparison of health-related quality of life issues of adolescents and young adults with cancer. Eur J Cancer Care (Engl).2018 Nov;27(6):e12980.
  6. US Department of Health and Human Services. Closing the Gap: Research and Care Imperatives for Adolescents and Young Adults with Cancer. Report of the Adolescent and Young Adult Oncology Progress Review Group. NIH publication 06-6067. US Department of Health and Human Services; 2006.
  7. van Leeuwen M et al.; EORTC QLG. Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health Qual Life Outcomes 2018 Jun 4;16(1):114.
  8. Aaronson NK et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76.
  9. Giesinger JM et al. Past and current practice of patient-reported outcome measurement in randomized cancer clinical trials: a systematic review. Value Health 2021;24(4):585–
  10. Smith AB et al. Reporting of health-related quality of life (HRQOL) data in oncology trials: a comparison of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (FACT-G). Qual Life Res 2014;23:971–6.
  11. Howell D et al. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol 2015;26:1846–58.
  12. Bjordal K et al. EORTC Quality of Life Group Guidelines for Developing Questionnaire Modules [Internet]. Brussels, Belgium: EORTC; 2021.
  13. Sodergren SC et al. Development of a Health-Related Quality of Life Tool for Adolescents and Young Adults With Cancer. JAMA Netw Open 2025 Dec 1;8(12):e2549071.
  14. Roth ME et al. Inclusion of Patient-Reported Outcomes in Adolescent and Young Adult Phase III Therapeutic Trials: An Analysis of Cancer Clinical Trials Registered on ClinicalTrials.gov. Value Health 2021;24(12):1820–7.