title: Surgical and oncology trials for rectal cancer: who will participate?
abstract: BACKGROUND
  The assessment of patients' and clinicians' willingness to participate in clinical trials is advisable as part of a feasibility exercise prior to the commencement of randomized controlled trials (RCTs) to ensure adequate support in terms of likely accrual to achieve the required sample size in a timely fashion. Furthermore, understanding why patients are unwilling to enter RCTs is imperative before the current trend of low participation can be reversed.
  
  
  METHODS
  Patients, colorectal surgeons, and medical and radiation oncologists, were presented with 5 different, detailed treatments for locally advanced rectal cancer. They were asked whether they would be willing to enter an RCT comparing each treatment choice. Patients who would not participate were asked to indicate their reason for refusal.
  
  
  RESULTS
  Patients' willingness to participate in each trial was consistently low (19% to 32%). Similar low levels of participation were indicated by each clinical subspecialty (15% to 38%). Of the scenarios, patients and clinicians were most willing to enter a trial investigating surgery plus preoperative radiotherapy. A dislike of randomization, a desire to be involved in decision-making, and quality of life considerations were the most commonly stated reasons for refusal.
  
  
  CONCLUSIONS
  This study highlights the difficulties in performing RCTs in surgery and oncology. However, results suggest that improvements in communication regarding randomization and clinical trial processes and the actual, rather than perceived, side effects of treatments are strategies that may enhance patient participation.
authors.affiliation: Surgical Outcomes Research Centre, Sydney South West Area Health Service & University of Sydney, Sydney, Australia. james.harrison@email.cs.nsw.gov.au
authors.forename: James D
authors.initials: JD
authors.lastname: Harrison
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Solomon
authors.forename: Jane M
authors.initials: JM
authors.lastname: Young
authors.forename: Alan
authors.initials: A
authors.lastname: Meagher
authors.forename: George
authors.initials: G
authors.lastname: Hruby
authors.forename: Glenn
authors.initials: G
authors.lastname: Salkeld
authors.forename: Stephen
authors.initials: S
authors.lastname: Clarke
mesh_terms: D001291:Attitude of Health Personnel; D003657:Decision Making; D013502:General Surgery; D006801:Humans; D008495:Medical Oncology; D010358:Patient Participation / Q000523:psychology*; D017060:Patient Satisfaction; D011788:Quality of Life; D018787:Radiation Oncology; D016032:Randomized Controlled Trials as Topic; D012004:Rectal Neoplasms / Q000503:physiopathology / Q000628:therapy*