Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)

Trials

Karen Lord¹  Bethany Taylor²  Angela Tod²  Clare Warnock³ 

[1] Glenfield Hospital, Mesothelioma UK/University Hospitals of Leicester NHS Trust;School of Nursing and Midwifery, The University of Sheffield;Specialist Cancer Services, Weston Park Hospital, Sheffield Teaching Hospital NHS Foundation Trust;

关键词: Mesothelioma;    Clinical trials;    Surgery;    Chemotherapy;    Randomisation;   

DOI  :  10.1186/s13063-019-3692-x

来源: DOAJ

【 摘 要 】

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. Trial registration ClinicalTrials.gov, NCT02040272. Registered on 20 January 2014.

【 授权许可】

Unknown