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

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 rese...

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Main Authors: Clare Warnock, Karen Lord, Bethany Taylor, Angela Tod
Format: Article
Language:English
Published: BMC 2019-10-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-019-3692-x
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author Clare Warnock
Karen Lord
Bethany Taylor
Angela Tod
author_facet Clare Warnock
Karen Lord
Bethany Taylor
Angela Tod
author_sort Clare Warnock
collection DOAJ
description 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.
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spelling doaj.art-aa625ece987642b1918ccb6c6c7698622022-12-22T00:27:55ZengBMCTrials1745-62152019-10-0120111010.1186/s13063-019-3692-xPatient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)Clare Warnock0Karen Lord1Bethany Taylor2Angela Tod3Specialist Cancer Services, Weston Park Hospital, Sheffield Teaching Hospital NHS Foundation TrustGlenfield Hospital, Mesothelioma UK/University Hospitals of Leicester NHS TrustSchool of Nursing and Midwifery, The University of SheffieldSchool of Nursing and Midwifery, The University of SheffieldAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3692-xMesotheliomaClinical trialsSurgeryChemotherapyRandomisation
spellingShingle Clare Warnock
Karen Lord
Bethany Taylor
Angela Tod
Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
Trials
Mesothelioma
Clinical trials
Surgery
Chemotherapy
Randomisation
title Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
title_full Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
title_fullStr Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
title_full_unstemmed Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
title_short Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
title_sort patient experiences of participation in a radical thoracic surgical trial findings from the mesothelioma and radical surgery trial 2 mars 2
topic Mesothelioma
Clinical trials
Surgery
Chemotherapy
Randomisation
url http://link.springer.com/article/10.1186/s13063-019-3692-x
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