title: Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST).
abstract: OBJECTIVE
  To measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST) and compare those between the computed tomography (CT) group and the control group.
  
  
  METHODS
  This study was a single centre randomised controlled trial with five annual screening rounds. Healthy current or former heavy smokers aged 50-70 years (men and women) were randomised 1:1 to a CT group and a control group. Heavy smokers were defined by having smoked ≥20 pack years and former smokers by being abstinent ≤10 years. Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking.
  
  
  RESULTS
  4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from baseline through rounds 2-5 for both the CT group and the control group (mean increase >0, p<.0001 for 3 of 4 possible scales). During rounds 2-5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CT group (mean Δ score >0 and p<.033).
  
  
  CONCLUSIONS
  Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile. The CT group experienced less negative psychosocial consequences compared with the control group, which might be explained by reassurance among those with normal screening results.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00496977.
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark. Electronic address: jakobra@sund.ku.dk.
authors.forename: Jakob F
authors.initials: JF
authors.lastname: Rasmussen
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark.
authors.forename: V
authors.initials: V
authors.lastname: Siersma
authors.affiliation: Department of Cardiothoracic Surgery, RT 2152, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.
authors.forename: J H
authors.initials: JH
authors.lastname: Pedersen
authors.affiliation: The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, 1014 Copenhagen K, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Brodersen
mesh_terms: D000328:Adult; D001007:Anxiety; D003718:Denmark / Q000453:epidemiology; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012307:Risk Factors; D011795:Surveys and Questionnaires; D014057:Tomography, X-Ray Computed
keywords: Adverse effects; Cancer screening; Computed tomography; Lung cancer; Psychosocial aspects; Randomized controlled trial; Spiral