2.2 Study components and procedures
2.2.1 Outline of the co-creation process
The informational content was developed through a four-phase co-creation process: (1) identifying key topics, (2) creating preliminary content and evaluating it through focus groups, (3) revising the content and reviewing it through a Delphi study, and (4) finalizing the content for dissemination (
Table 2).
Table 2. Phases of Co-Creation of the informational content.
|
Phase |
Aim | Key activities | Participants | Output |
|---|
| 1. Identification of key topics | Define content topics to be covered on the website |
| Research team | List of prioritized topics |
| 2. Content creation and focus groups | Draft content and collect user feedback |
• Systematic literature searches for topics identified in phase 1 • Draft content by experts • Readability check23 • Focus groups with support network members
| Experts and support network members | Revised draft content |
| 3. Delphi study | Achieve expert consensus on content quality |
| Experts and support network members (user panel) | Consensus-approved content |
| 4. Finalization and dissemination | Translate, adapt, and publish |
• Country-specific adaptations, including translation into multiple languages and the addition of country-specific resources • Integration into PanCare website
| Research team, e-QuoL partners | Multilingual, web-based, informational content |
The co-creation process involved support network members at multiple stages. First, the topics were informed by the information and support needs expressed by support network members in the European e-QuoL Needs Study.17 Subsequently, support network members actively contributed to refining the preliminary informational content through focus groups, and their feedback was incorporated into revised versions before the content was reviewed by experts and support network members in the Delphi study. This iterative process ensured that the informational content was tailored to the needs of support network members while maintaining high scientific quality.19
The four-phase development process commenced in January 2024 and is expected to be completed in December 2027. At the time of writing, development of the preliminary informational content, participant recruitment, and data collection had been completed, while data analysis, finalization, and dissemination of the informational content are ongoing.
Phase 1: Identification of key topics
Phase 1 focused on identifying the main topics that should be covered in the informational content. Topics were selected based on systematic reviews on the information needs of support network members of CAYACS9,10 and findings from the European e-QuoL Needs Study, which assessed needs across support network members from 19 countries.17 To prevent duplication of information, existing content on the PanCare website was reviewed.16 As the PanCare materials primarily target CAYACS, specific aspects relevant to support network members—such as understanding survivors’ experiences, communicating about late effects, and providing adequate support17—were included to ensure the new content complements rather than replicates existing resources.
Phase 2: Content creation and focus groups
Phase 2 involved the development of preliminary informational content by experts in childhood, adolescent, and young adult (psycho-)oncology, including members of the Childhood Cancer Research team at the University of Lucerne and affiliated partners of the e-QuoL project. Sources included international guidelines (e.g., International Guideline Harmonization Group [IGHG]22), literature reviews, peer-reviewed research, and clinical expertise from psychologists and healthcare professionals. To make sure all relevant literature reviews were included, systematic literature searches were conducted for each domain for which informational content was developed (Appendix 1).
The informational content was written in accessible language to facilitate understanding. To ensure readability, the Hemingway Editor tool was used, with a target readability grade of ≤9, reflecting the average adult reading level.23 Content was developed in different formats (text, factsheets, brochures, and videos) and followed a standardized structure to promote clarity and consistency. Each section included a definition of the challenge, its prevalence, coping strategies, and additional resources. Once the preliminary drafts had been completed, focus groups with support network members evaluated the relevance, clarity, completeness, and helpfulness of the informational content.
Phase 3: Delphi study
In Phase 3, the revised content, based on focus group feedback, underwent consensus-based evaluation in a Delphi study to iteratively assess and improve its quality.18 The content was evaluated by a panel of experts and support network members of CAYACS. During the Delphi process, revisions were made between rounds to incorporate panel feedback.
Phase 4: Finalization and dissemination
In Phase 4 (ongoing), the informational content will undergo final editing and country-specific adaptation, including translation into the relevant European languages and cultural validation. Initial translations will be generated using artificial intelligence (AI)-assisted translation and subsequently reviewed by native-speaking e-QuoL partners to ensure linguistic accuracy and cultural appropriateness.
Where necessary, country-specific adaptations will be made to reflect differences in healthcare systems, available resources, and cultural context. In addition, a dedicated “Resources per country” section will provide links to national information sources, organized by topic (e.g., follow-up care, patient organizations, and psychosocial support; Appendix 2
). This section will be completed by e-QuoL partners from the respective countries.
Once finalized, the content will be hosted on the PanCare website16 and made available in English and the languages of participating e-QuoL countries. Translations will be implemented in phases to support feasibility.
2.2.2 Focus groups
Aim
The aim of the focus groups was to gather end-user feedback on the relevance, clarity, completeness, helpfulness, and preferred format (e.g., text, factsheets, videos) of the preliminary informational content.
Participants
Eligible participants were English-speaking members of the support network of CAYACS (e.g., parents, siblings, partners) aged ≥16 years and residing in Europe (
Table 3). CAYACS were defined as individuals diagnosed with cancer before the age of 25 years, who had completed treatment and were free of active disease. English proficiency was required because the preliminary informational content was developed in English and a shared language was necessary for the discussions. The minimum age of 16 years was selected because younger children and adolescents may have different needs and preferences regarding the presentation of information.
Table 3. Overview focus group and delphi study participants.
| Aspect | Focus groups | Delphi study |
|---|
| Study period | 2 September 2025–16 January 2026 | 14 January 2026–30 April 2026 |
| Target group | Support network members of CAYACSa, e.g., parents, siblings, and partners | Experts (oncologists, psychosocial specialists, e-QuoL team members, support network members) |
| Eligibility criteria | ≥16 years, English-speaking, living in Europe, interested in cancer-related information | ≥16 years, English-speaking, living in Europe |
| Sample size | 13 participants | 52 participants |
| Recruitment | PanCare, CCI Europe, e-QuoL partners, patient and parent organizations, hospitals, social media channels | PanCare, e-QuoL partners, patient and parent organizations, hospitals, pediatric oncology working and research groups, social media channels |
| Language | English (shared discussion language) | English |
| Informed consent | Online via Qualtrics (Provo, UT) | Online via Qualtrics (Provo, UT) |
The final sample size was determined by data saturation, defined as the point at which no new insights emerged. As this was a qualitative study, no formal sample size calculation was performed.
Study procedures
Participants were recruited through large cancer survivorship platforms (PanCare,16 Childhood Cancer International (CCI) Europe24). The e-QuoL partners shared the leaflets with patients and parents’ organizations and hospitals in their respective countries. The leaflets were also distributed on the e-QuoL project website and via posts on LinkedIn.
Interested individuals registered either (a) by responding to an invitation from CCI Europe, which forwarded their contact details (name and email address) to the study team, or (b) by scanning a Quick Response (QR) code linked to a secure online registration form created in Qualtrics (Provo, UT).
Prior to participation, focus group members provided informed consent and completed a short questionnaire in Qualtrics (Provo, UT) on demographic and contextual characteristics (age, gender, country of residence, survivor’s diagnosis and age at diagnosis, survivor’s (neurocognitive) late effects, and follow-up care status). These characteristics were collected to describe the study sample. All data were collected in broad categories to ensure anonymity.
Focus groups were conducted online via Microsoft Teams and lasted approximately 90 minutes, each covering a maximum of three content domains. Participants received the preliminary content at least one week in advance for review. At the start of each session, the procedure was explained and questions were addressed. Discussions focused on participants’ perspectives on the preliminary content. Sessions were facilitated by a moderator and co-moderator using a structured topic guide (Appendix 3) containing facilitation recommendations, discussion rules, and structured open-ended questions and probes. Two participants who were unable to attend a scheduled focus group completed an individual interview using the same topic guide. All sessions were video recorded via Microsoft Teams to capture both verbal and non-verbal cues and allow accurate attribution of participants’ comments.
Analysis
Focus group recordings were transcribed verbatim. Initial transcripts generated by Microsoft Teams were manually reviewed, corrected where necessary, and finalized. To enable revision of the informational content for the subsequent Delphi study, a preliminary analysis of the focus group feedback was conducted. The full qualitative analysis is ongoing and will use qualitative content analysis.25 A deductive approach will be applied using predefined categories and subcategories based on the study aims (relevance, clarity, completeness, and helpfulness) and the structured topic guide (Appendix 3). Where necessary, additional categories will be developed inductively from the data. One researcher will code the transcripts, and a second researcher will review the coding. Any discrepancies will be resolved through discussion until consensus is reached. MAXQDA software (VERBI Software, Berlin, Germany) will be used to support the qualitative analysis. Quantitative questionnaire data will be analyzed using descriptive statistics in Stata (StataCorp LLC, College Station, TX, USA).
2.2.3 Delphi study
Aim
The aim of the Delphi study was to achieve consensus among experts and support network members on the relevance, clarity, completeness, and credibility of the developed informational content. Building on the revisions made following the focus groups, the Delphi study provided a structured expert review and consensus process to ensure the quality and credibility of the final informational content prior to dissemination.
Participants
Eligible participants were English-speaking experts, such as pediatric oncologists, psychosocial specialists, and researchers in the field, as well as representatives of the support network of CAYACS (e.g., parents, partners, siblings, and close friends aged ≥16 years) living in Europe (
Table 4).
Table 4. Overview of domains covered in the informational content.
| Domain | Subdomain |
|---|
| Cancer-related health information | Cancer risk for family members, how to address potential risks, including genetic testing options |
| Information on cancer recurrence and subsequent tumors (distinction between recurrence vs. subsequent tumors; prevention) |
| Supporting CAYACS with late effects and talking about cancer-related challenges |
| Psycho-emotional consequences | Emotional and mental health (psychosocial challenges CAYACS face; mental health challenges in support network members; resilience) |
| Coping (worry, anxiety, feeling down; uncertainty about CAYACS’ future; fears about disability/deterioration; staying positive and finding meaning) |
| Parenting a survivor and their sibling(s) (parents only) |
| Long-term follow-up care and surveillance (LTFU) | Long-term Follow-up (LTFU) (importance for early detection of late effects, frequency, supporting CAYACS with LTFU) |
| Supporting CAYACS with their care (transition to adult health care; providing input during appointments; expressing concerns to healthcare providers) |
| Insurance and financial consequences | Financial and insurance consequences, right to be forgotten |
| Education and employment | Challenges for CAYACS (impact on education and employment): what is important to know for support network members |
| Challenges for parents and strategies for coping and support |
| Services and finding support | Peer support (websites, finding others with similar experience, local support groups) |
| Emotional support (how to find professional counseling/therapy) |
| Practical support (transportation, accessibility, daily challenges) |
| Sexuality (partners only) | Changes in sexuality and relationships after cancer (impact of treatment incl. Fertility, libido, sexual relationship, coping strategies for partners, communication) |
| Support and counseling for sexual concerns (where to seek help, counseling) |
To account for potential attrition between Delphi rounds, we aimed to obtain at least six reviews for each informational content draft. As 15 informational content drafts were evaluated, this corresponded to a target of at least 90 completed reviews across all Delphi rounds.
Study procedures
Participants were recruited through the PanCare platform. In addition, e-QuoL partners distributed recruitment leaflets to patient and parent organizations and hospitals in their respective countries. Healthcare professionals and researchers were recruited through pediatric oncology clinical and research networks. Recruitment leaflets were also shared via the e-QuoL project website and LinkedIn.
Efforts were made to ensure a balanced mix of clinical experts, psychosocial professionals, and support network representatives in the panel. Participants received up to two reminder emails to minimize attrition between Delphi rounds. Response rates and attrition across Delphi rounds will be reported in the final study publication together with the results of the analyses.
Prior to participation, panel members provided informed consent and completed a short questionnaire on demographic and professional characteristics (age, gender, country of residence, role in relation to CAYACS, and, for professionals, profession and years of experience). All data were collected in broad categories to ensure anonymity.
The Delphi study was conducted online using the Qualtrics (Provo, UT) survey platform. Panel members received the informational content for review and were invited to provide feedback in iterative rounds. In each round, participants rated the content and provided open-ended feedback using a questionnaire adapted from the MAPPinfo checklist.26 The checklist, originally developed to assess the quality of health information materials, was simplified for use in the Delphi study and adapted to include psychosocial aspects relevant to support network members.
The questionnaire (Appendix 4) covered four domains: relevance for the target group, completeness of information, credibility, and clarity and presentation. Participants responded on a four-point scale (strongly disagree, disagree, agree, strongly agree). For each domain, an average score across all items was calculated for each panel member. Consensus was considered achieved when at least 75% of panel members had an average score > 2.5 on the 1–4 Likert scale (1 = strongly disagree, 4 = strongly agree).27 When consensus was not reached, the informational content for that domain was revised based on participants’ qualitative feedback and presented again in the subsequent Delphi round.
Analysis
Quantitative ratings from the Delphi questionnaire were analyzed using descriptive statistics (percentage agreement per round) in Stata (StataCorp LLC, College Station, TX, USA) to determine the level of consensus. A preliminary qualitative analysis of participants’ comments was conducted to revise the informational content between Delphi rounds.
The full qualitative analysis is ongoing and will use qualitative content analysis25 with predefined categories and subcategories based on the study aims (relevance, clarity, completeness, and credibility) and the Delphi assessment tool (Appendix 4). Two researchers will independently code the qualitative comments and resolve discrepancies through discussion until consensus is reached. MAXQDA software (VERBI Software, Berlin, Germany) will be used to support the qualitative analysis.
2.3 Ethical approval and consent to participate
The project was approved by the Ethics Committee of the University of Lucerne, Switzerland (Number #2025–025, August 25, 2025). It complies with the Swiss Federal Act on Data Protection (235.1, June 19, 1992) and the Swiss Human Research Act (810.30, September 30, 2011).
Participation was voluntary, and informed consent was obtained electronically via Qualtrics (Provo, UT) prior to participation in the e-QuoL Needs survey, the focus groups, and the Delphi study. Participants received detailed study information outlining the project’s purpose, procedures, voluntary nature of participation, data protection, and contact details of the research team.
Where applicable, participants aged 16 and 17 years provided their own electronic informed consent. This procedure was approved by the Ethics Board of the University of Lucerne for all study components described in the protocol. It was also in line with the age requirements for parental consent for children’s participation in research in the countries where recruitment took place, as reported by the European Union Agency for Fundamental Rights (https://fra.europa.eu/et/publication/2019/child-participation-research).
The Ethics Committee of North-Western Switzerland confirmed that the Needs Study did not fall within the scope of the Human Research Act because only anonymized research data were collected. The focus groups did not include minors, and the Delphi study did not assess any medical information. Country-specific information on ethics approval dates and reference numbers, where applicable, is available in the Extended Data accompanying this study on Zenodo.28
The study involved minimal risk and did not include the collection of sensitive personal data. Focus group discussions focused on feedback regarding the informational content rather than participants’ personal experiences. Some cancer-related material could nonetheless have elicited emotional responses. To minimize this risk, trained moderators facilitated the sessions, created a respectful environment, and monitored participants’ well-being. Participants could skip questions or withdraw at any time without consequences. No financial compensation was provided.
All research data were anonymized prior to analysis. Identifiable information (e.g., consent forms and contact details) was stored securely at the University of Lucerne, separately from the research data. Video recordings of the focus groups will be deleted once the scientific publications have been completed. Transcripts, survey responses, and consent forms will be retained for 10 years after completion of the project. Results will be disseminated through peer-reviewed publications and scientific conferences.
