The role of Information and Consent Formin patients’ decision-making and understanding in oncology clinical trials: a mixed-methods study

Background: Informed consent is a cornerstone of ethical clinical research. However, the increasing length and complexity of information and consent forms (ICFs) raise concerns about their effectiveness in ensuring truly informed participation. This study examined the role of written ICFs in cancer patients’ decision-making and their practical use during clinical trial participation. Methods: We conducted a mixed-methods combined quantitative and qualitative analyses. Semi-structured interviews were conducted with 29 cancer patients recently enrolled in clinical trials, 18 physicians involved in patient inclusion, and 15 clinical research nurses. Data were analyzed thematically and statistically using IRaMuTeQ and JAMOVI software. Interview transcripts underwent thematic analysis. Results: Patients’ decisions to participate were driven almost entirely by oral discussions with their physicians rather than by written information. Sixty-five percent of patients reported not reading, or only skimming, the ICF before signing. Trust in the physician was the main determinant of consent (mentioned by 86% of participants), often accompanied by a sense of having no therapeutic alternative. The ICFs—averaging 35 pages—were described as overly lengthy, repetitive, and legalistic, perceived more as documents protecting sponsors than as tools for patient understanding. Physicians confirmed that consent was based on the interpersonal relationship rather than the written form, and most admitted not reading ICFs in full themselves. Nurses noted that patients rarely referred to ICFs after inclusion and instead relied on simplified summary sheets they had developed, which outlined key practical details (drug name, trial phase, visit schedule). These visual tools improved comprehension and adherence. Discussion: Findings indicate that current ICFs have limited impact on decision-making and little practical value during the trial. While legally indispensable, their complexity undermines comprehension and meaningful consent. Restructuring is therefore needed to enhance their communicative function. Conclusion: ICFs should be concise (ideally ≤ 5 pages), emphasizing essential elements—trial rationale, phase, benefit–risk balance, alternatives, and visit schedule—while placing regulatory details in annexes. A simplified and patient-centered format, complemented by clear oral discussion, would promote genuine understanding and reinforce ethical standards of informed consent in clinical research.