Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

• Published in: European journal of cancer care Vol. 20; no. 4; pp. 445 - 454
• Main Authors: DELLSON, P., NILBERT, M., BENDAHL, P-O., MALMSTRÖM, P., CARLSSON, C.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.07.2011; Hindawi Limited
• Subjects: Aged; Breast Neoplasms - psychology; cancer; Cancer and Oncology; Cancer och onkologi; Clinical Medicine; clinical trials; Clinical Trials as Topic; Communication; Female; focus group interview; Focus Groups; Humans; informed consent; Informed Consent - psychology; Informed Consent - standards; Klinisk medicin; Medical and Health Sciences; Medicin och hälsovetenskap; Middle Aged; Nursing; Patient Advocacy; patient advocates; Patient Education as Topic; patient involvement; Qualitative Research; Surveys and Questionnaires; Sweden
• DOI: 10.1111/j.1365-2354.2010.01207.x
• ISSN: 0961-5423; 1365-2354

DELLSON P., NILBERT M., BENDAHL P‐O., MALMSTRÖM P. & CARLSSON C. (2010) European Journal of Cancer Care
Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials.