Navigating ethical challenges in the FORTEe randomised controlled trial: a multi-centre staff survey on exercise intervention for children and adolescents undergoing cancer treatment.

BACKGROUND

The FORTEe randomised controlled trial (NCT05289739) investigates an exercise intervention for children and adolescents undergoing cancer treatment. Conducting research with this vulnerable population poses unique ethical challenges, including participant burden, child autonomy, and parental decision-making. This study explored the ethical experiences of healthcare professionals (HCPs) involved in the trial.

METHODS

A multicentre survey was conducted across ten clinical sites in Europe using a structured, browser-based questionnaire comprising both closed and open-ended questions. Domains included burden and benefits assessment, informed consent, child autonomy, parental influence and moral distress. Quantitative responses were analysed descriptively, while qualitative data underwent content analysis.

RESULTS

Seventy-nine HCPs participated, including exercise professionals (n = 30), physicians (n = 19), nurses (n = 8), psychologists (n = 5), social workers (n = 3), one social scientist, one medical ethicist and 12 individuals in other roles. A large majority of respondents (86.1%) agreed or strongly agreed that the overall burden-benefit balance of trial participation was appropriate, while 11.4% were unsure and 2.5% disagreed. Open-text responses described perceived challenges related to questionnaire burden, logistical demands, and emotional discomfort associated with control-group allocation. Informed consent procedures were generally perceived as appropriate. However, some respondents reported situations in which parental influence appeared to outweigh children’s expressed preferences, and difficulties were noted in assessing children’s evolving decision-making capacity. Among HCPs who described prognosis-related events (n = 45), 68.9% described experiences they associated with moral distress, particularly in relation to communication and decisions regarding continuation of participation.

CONCLUSION

The trial's ethical climate was largely perceived as positive, though emotional and logistical burdens were noted. Reports of emotional discomfort and moral distress among staff highlight the ethical tensions between research integrity and individual well-being. Furthermore, divergent views on children’s capacity to give consent suggest the need for clearer guidance on paediatric autonomy and shared decision-making. IMPLICATIONS: Ethically sound paediatric research must address real-world burdens and emotional dynamics beyond procedural compliance. Findings from the FORTEe trial staff survey highlight the importance of flexible, child-centred approaches, sustainable access to beneficial interventions, and institutional structures that promote ethical reflection. TRIAL REGISTRATION: Registered on ClinicalTrials.gov (NCT05289739, 21 March 2022) and in the German Clinical Trials Register (DRKS00027978, 28 January 2022).