Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)

Trials
Emily HarropPublished on behalf of the BOLERO Trial Management Group (TMG)

Abstract

Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation. Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes. The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive 'sense' that favoured the new technology and had carried out their own inquiries, including Internet research and talking...Continue Reading

References

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Citations

Sep 17, 2016·Urology·Maximilian Burger
Jul 14, 2017·The British Journal of Surgery·C A RogersUNKNOWN By-Band-Sleeve study investigators
Feb 9, 2019·Scandinavian Journal of Caring Sciences·Trine A GregersenJette Ammentorp
Jun 4, 2019·Journal of Alzheimer's Disease : JAD·Clare ClementJeremy Horwood
Dec 24, 2019·Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland·M J LeeS R Brown
Aug 3, 2019·Surgical Endoscopy·Asya OfshteynSharon L Stein
Dec 12, 2016·Research Involvement and Engagement·Stephanie EstcourtMark Daly
Oct 8, 2020·The Cochrane Database of Systematic Reviews·Catherine HoughtonLinda M Biesty
Nov 6, 2020·Journal of Multidisciplinary Healthcare·Bianca ViljoenSonja March
Mar 2, 2021·Health Technology Assessment : HTA·Jonathan A CookAndrew J Carr
Mar 19, 2021·Journal of Evaluation in Clinical Practice·Julius Sim

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Software Mentioned

SPARE
ProtecT
QUEST
BOLERO

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