title: Cancer patients' acceptability of incorporating an epidemiology questionnaire within a clinical trial.
abstract: OBJECTIVE
  Understanding the influence or impact of epidemiological factors on cancer outcomes in clinical trials can broaden our knowledge of disease, trial populations and therapeutic effects thus leading to improved patient care. However, there is a lack of data on cancer patients' compliance with an epidemiology questionnaire in the context of a clinical trial.
  
  
  METHODS
  Cancer patients were provided with a hypothetical scenario and surveyed regarding their willingness and preferences to complete an epidemiology questionnaire if incorporated into a cancer therapy trial. Patient compliance with completing a voluntary epidemiology questionnaire and trial coordinators perceptions therein were separately determined in the NCIC Clinical Trials Group HN.6 clinical trial, an ongoing randomized phase III trial comparing two first-line treatment regimens in patients with locoregionally advanced head and neck cancer.
  
  
  RESULTS
  Of 617 cancer patients from community, academic and tertiary cancer centres, the majority were willing to complete an epidemiology questionnaire either unconditionally (45%), or provided it did not inconvenience them (31%); 4% would refuse. Patients preferred shorter questionnaires of 30-50 questions requiring 10-20 min to complete, administered over 1-3 sessions. Patients were less willing, but still compliant, to answer questions relating to sexual history (71%) and annual household income (66%) relative to other questions (>90%). Eighteen percent thought that the questionnaire should be mandatory, with 31% believing that they may benefit personally from such research. In the HN.6 trial, compliance averaged 94.8% per question.
  
  
  CONCLUSIONS
  Cancer patients are very willing to complete epidemiology questions in clinical trials.
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada HOPE Directorate, St. James's Hospital, Dublin, Ireland Scuffe@stjames.ie.
authors: Sinead
authors: S
authors: Cuffe
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Henrique
authors: H
authors: Hon
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Kimberly
authors: K
authors: Tobros
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Osvaldo
authors: O
authors: Espin-Garcia
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Yonathan
authors: Y
authors: Brhane
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Luke
authors: L
authors: Harland
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Ehab
authors: E
authors: Fadhel
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Lawson
authors: L
authors: Eng
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Anthony
authors: A
authors: LaDelfa
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: John
authors: J
authors: Waldron
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Lillian L
authors: LL
authors: Siu
authors: NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
authors: Bingshu E
authors: BE
authors: Chen
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Wei
authors: W
authors: Xu
authors: BC Cancer Agency, Vancouver, BC, Canada.
authors: Christine
authors: C
authors: Simmons
authors: Southlake Cancer Centre, Newmarket, ON, Canada.
authors: Zahra
authors: Z
authors: Kassam
authors: NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
authors: Alexander
authors: A
authors: Montenegro
authors: NCIC Clinical Trials Group, Queen's University, Kingston, ON, Canada.
authors: Wendy R
authors: WR
authors: Parulekar
authors: Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
authors: Geoffrey
authors: G
authors: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology* / Q000628:therapy*; D009864:Ontario; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D035842:Research Subjects / Q000523:psychology*; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Epidemiology; cancer; clinical trials; head and neck cancer; patient preferences; questionnaires