Patients find cancer drug trial leaflets too long, incomprehensible, and even intimidating, according to research published in the international journal Sociology of Health and Illness.
Author Mary Dixon-Woods, Professor of Medical Sociology at the University of Leicester Department of Health Sciences said, “These information sheets are poorly aligned with patients’ information needs and how they really make decisions about whether to join a cancer trial. Some patients did find them very useful, but many others paid them little attention. They preferred to rely on discussions they had with their doctor to make up their minds.”
The study was conducted in cooperation between the departments of Health Sciences and Cancer Studies at the University of Leicester, and it followed 13 cancer trials. Researchers examined information sheets during the planning process, from preparation by researchers leading the trials, to review and approval by research ethics committees. The study interviewed 26 patients offered participation in the trials and thus given the information sheets.
“The problem is that information sheets are trying to do too many things. They end up having many of the features of a legal contract. Patients often find them far too long and incomprehensible, and even intimidating. In fact, many patients believed that the information sheets weren’t really produced for their benefit at all, but were more about researchers and institutions ‘covering their backs,’” said author Dr Natalie Armstrong, Lecturer in Social Science Applied to Health.
The study offers suggestions to improve cancer trial information sheets. “Rather than using standardized templates, it might be better to have a list of principles that could be used when writing information sheets. It could also be valuable to involve patients themselves in helping to write and review them,” commented Dr Armstrong. “But we also have to accept that patients may continue to make their decisions about taking part in trials based on trust in their doctor, no matter how well written the information sheets are. We need to find ways to support doctors when recruiting to trials.”
Source: University of Leicester.