Warnock, C., Lord, K., Taylor, B. et al. (1 more author) (2019) Patient experiences of participation in a radical thoracic surgical trial : findings from the mesothelioma and radical surgery trial 2 (MARS 2). Trials, 20. 598.
Abstract
Background
The Mesothelioma and Radical Surgery Trial (MARS 2) aims to evaluate a surgical procedure by comparing chemotherapy and surgery against chemotherapy alone. The pilot study for MARS 2 evaluated the viability of recruitment. Challenges have been reported in conducting clinical research into thoracic surgical treatments and evidence is required to improve our understanding of patient experiences of trial procedures, trial treatments and the factors that influence participation.
Methods
This longitudinal qualitative study was nested within the MARS 2 pilot. Semi-structured telephone interviews were conducted with 15 participants in the MARS 2 trial. Interviews were conducted post-randomisation, post-surgery (surgery arm) and at 6 and 12 months. Altogether, 41 interviews were carried out. The data were analysed using framework techniques.
Results
Challenges were identified regarding the volume and complexity of information given to participants, and their understanding of clinical equipoise and randomisation. Factors influencing participation included having an opportunity to undergo surgery, a self-assessment of their ability to cope with trial treatments, maintaining a positive approach and altruism. Obstacles included the logistics of traveling for treatment in an unfamiliar setting. Negative consequences of trial participation included increased uncertainty amplified by multiple care providers and unclear transition arrangements after the trial.
Conclusions
Participants’ descriptions provided insights that have implications for care for mesothelioma trial patients. The need for healthcare staff to be alert to the potential for misunderstanding, particularly when presenting treatment options, was identified. Patients perceived and derived benefits from taking part in the trial but experienced some negative consequences. These should be anticipated and managed proactively.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2019 The Authors. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | Mesothelioma; Clinical trials; Surgery; Chemotherapy; Randomisation |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 12 Nov 2019 11:02 |
Last Modified: | 12 Nov 2019 11:02 |
Status: | Published |
Publisher: | Springer Science and Business Media LLC |
Refereed: | Yes |
Identification Number: | 10.1186/s13063-019-3692-x |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:153351 |