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

Our plain-English summary of Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2), by C. Warnock, K. Lord, B. Taylor, et al (Trials, 2019).

The study

• Authors: C. Warnock, K. Lord, B. Taylor, A. Tod
• Journal: Trials
• Published: 2019;20(1):598
• Cited by: 12 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

In plain English

This qualitative study was nested within the MARS 2 pilot. MARS 2 is a randomised trial for malignant pleural mesothelioma that compares standard chemotherapy alone with chemotherapy plus the operation extended pleurectomy decortication. Researchers interviewed 15 trial participants by telephone. Nine were receiving surgery and chemotherapy and six chemotherapy alone; 14 were men, and participants were aged 59 to 82. Of a possible 54 interviews, 41 were completed. All participants said they felt informed and not pressured to join. However, six did not fully understand randomisation, and three thought a doctor chose their treatment. Some inferred that the doctor explaining the trial preferred surgery. Reasons for joining included the chance of surgery, judging themselves fit enough, staying positive and helping future treatment. Travelling for treatment away from home was an obstacle. Five did not get their preferred treatment. Participants described uncertainty from poorly coordinated care between providers and unclear post-trial plans. The authors concluded that staff should be alert to possible misunderstanding, and that negative consequences should be anticipated and managed proactively. They noted the sample was relatively small.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Longitudinal qualitative study (semi-structured telephone interviews, analysed with the framework approach) nested within the MARS 2 pilot randomised trial
• Who was studied: 15 patients with malignant pleural mesothelioma taking part in the MARS 2 pilot (16 invited, 1 declined). Nine received chemotherapy and surgery and six chemotherapy alone. Eight were from Leicester and 7 from Sheffield. Fourteen were male. Participants were aged 59 to 82 (mean 70.13).
• Exposure: Not an asbestos exposure study. It examined experience of the trial treatments: standard chemotherapy (platinum and pemetrexed) with or without extended pleurectomy decortication (EPD)
• Main results:
  • Of a potential 54 interviews, 41 were carried out; seven participants completed all their scheduled interviews
  • All participants reported feeling informed about the treatment options, having opportunities to discuss them, and not feeling under pressure to participate
  • Some participants inferred from their trial consultation that surgery could be the treatment preferred by the doctor explaining the trial
  • Six participants did not fully understand randomisation; three thought a doctor made the treatment decision
  • Before randomisation, four participants had no treatment preference and seven preferred surgery
  • Four participants preferred chemotherapy
  • Five participants did not get their preferred treatment
  • For participants keen to receive surgery, joining the trial was a way to get it
  • Participants' own assessment of their ability to cope physically with treatment influenced their decision
  • Many spoke of the importance of taking a positive approach to their illness and treatment
  • Most participants described altruism, through improving future treatment, as a motivating factor
  • Some participants had considered not taking part because of the logistics of receiving treatment some distance from home
  • Fragmented care between treatment and service providers created uncertainty and added to participants' anxiety
  • The end of treatment and of the trial triggered uncertainty among participants
  • Participants described learning that their cancer was an occupational disease, which had legal and financial ramifications
• The authors' conclusion: The authors concluded that healthcare staff should be alert to the potential for misunderstanding, particularly when presenting treatment options. They also concluded that patients perceived and derived benefits from the trial. Negative consequences, such as uncertainty about treatment plans and arrangements at trial completion, should be anticipated and managed proactively.
• Limitations the authors state:
  • The sample size was relatively small
  • The findings are limited to mesothelioma patients who agreed to take part in the MARS 2 trial, so saturation may not have been achieved
  • Consultations were not directly observed, so it is not known whether what participants reported was actually said or was a misunderstanding
  • The experiences of people who declined participation before or after randomisation were not captured

Topics

The National Library of Medicine indexes this study under subjects our site covers: Mesothelioma.

Medical terms in this study, explained in our Lexicon: Mesothelioma, Chemotherapy, MARS 2 Trial.

Related studies

• Strategies to address recruitment to a randomised trial of surgical and non-surgical treatment for cancer: results from a complex recruitment intervention within the Mesothelioma and Radical Surgery 2 (MARS 2) study — N. Mills, N. Farrar, et al. (2024)
• Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma — E. Lim, L. Darlison, et al. (2020)
• Multimodal therapy of malignant pleural mesothelioma: is the replacement of radical surgery imminent? — J. Lindenmann, V. Matzi, et al. (2013)
• A survey of opinions and beliefs concerning surgery for malignant pleural mesothelioma amongst 802 members of the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Thoracic Surgeons (ESTS) and the Society of Thoracic Surgeons (STS) — T. Treasure, E. Internullo, et al. (2011)
• Evolution of locoregional treatment for peritoneal carcinomatosis: single-center experience of 308 procedures of cytoreductive surgery and perioperative intraperitoneal chemotherapy — T.C. Chua, W. Liauw, et al. (2011)
• Malignant pleural mesothelioma and the Society of Thoracic Surgeons Database: an analysis of surgical morbidity and mortality — B.M. Burt, R.B. Cameron, et al. (2014)

Browse more research in Trials, or return to medical research.