Abhyankar, P, Velikova, G, Summers, B et al. (1 more author) (2016) Identifying components in consent information needed to support informed decision making about trial participation: an interview study with women managing cancer. Social science & medicine, 161. pp. 83-91. ISSN 0277-9536
Abstract
Background: 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. Design: 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. Results: 21/41 eligible 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. Conclusions: 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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016, Elsevier. This is an author produced version of a paper published in Social science & medicine. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | shared decision making, informed consent, trial participation, cancer treatment, decision aids. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Business (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 07 Jun 2016 11:15 |
Last Modified: | 29 Jul 2017 21:32 |
Published Version: | http://dx.doi.org/10.1016/j.socscimed.2016.05.040 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.socscimed.2016.05.040 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:100449 |