Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer.
Research governance requires patients give informed consent to participate in clinical trials. However, there are concerns that consent information may not support patient participation decisions. This study investigates the utility of consent information in supporting women's trial participation decisions when receiving treatment for cancer.



An interview study with women receiving cancer treatments at a medical oncology outpatient clinic in Yorkshire (UK). All women over 18 years, not admitted to a hospital ward and who had currently or previously been invited to take part in a trial were invited to take part in the study over a three month period. Interviews were audio-tape recorded, transcribed and analysed using thematic analysis.



Of those eligible (n = 41), 21 women with breast (n = 11), ovarian (n = 8) and endometrial (n = 2) cancer participated (mean age = 57 years). Eighteen had made at least one trial decision and three were considering taking part in a trial. Findings are synthesised under two analytical themes: 1) Influence of the cancer and cancer treatment context on decision making for trial participation; and 2) Experiences of the consenting process and their influence on decision making.



Designing trial information to represent explicitly the trial participation decision as being between standard care and study-related care options is more likely to effectively support patients in making informed decisions between standard care treatments and taking part in a trial.
Leeds Institute of Health Sciences, University of Leeds, UK. Electronic address: purva.abhyankar@stir.ac.uk.
Purva
P
Abhyankar
Leeds Institute for Molecular Medicine, St James's Institute of Oncology, University of Leeds, UK.
Galina
G
Velikova
Centre for Decision Research, Leeds University Business School, UK.
Barbara
B
Summers
Leeds Institute of Health Sciences, University of Leeds, UK.
Hilary L
HL
Bekker
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000554:Ambulatory Care Facilities / Q000458:organization & administration; D003430:Cross-Sectional Studies; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology / Q000592:standards*; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy; D010358:Patient Participation / Q000379:methods* / Q000523:psychology; D018579:Patient Selection / Q000941:ethics*; D036301:Qualitative Research; D011795:Surveys and Questionnaires; D006113:United Kingdom
Cancer treatment; Decision aids; Informed consent; Shared decision making; Trial participation