title: Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial.
abstract: BACKGROUND
  Psychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC).
  
  
  METHODS
  This study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs.
  
  
  CONCLUSIONS
  We created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer.
  
  
  BACKGROUND
  This trial is registered in the Netherlands Trial Register NTR4034.
authors.affiliation: Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands. c.schuurhuizen@vumc.nl.|Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. c.schuurhuizen@vumc.nl.
authors.forename: Claudia S E W
authors.initials: CS
authors.lastname: Schuurhuizen
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. a.braamse@ggzingeest.nl.
authors.forename: Annemarie M J
authors.initials: AM
authors.lastname: Braamse
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. a.beekman@ggzingeest.nl.
authors.forename: Aartjan T F
authors.initials: AT
authors.lastname: Beekman
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. h.bomhof-roordink@lumc.nl.
authors.forename: Hanna
authors.initials: H
authors.lastname: Bomhof-Roordink
authors.affiliation: VU University, Faculty of Health Science, Amsterdam, the Netherlands. j.e.bosmans@vu.nl.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Bosmans
authors.affiliation: Department of Clinical Psychology, VU University, Amsterdam, the Netherlands. p.cuijpers@vu.nl.
authors.forename: Pim
authors.initials: P
authors.lastname: Cuijpers
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. a.hoogendoorn@ggzingeest.nl.
authors.forename: Adriaan W
authors.initials: AW
authors.lastname: Hoogendoorn
authors.affiliation: Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands. i.konings@vumc.nl.
authors.forename: Inge R H  M
authors.initials: IR
authors.lastname: Konings
authors.affiliation: Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands. m.vanderlinden@vumc.nl.
authors.forename: Mecheline H M
authors.initials: MH
authors.lastname: van der Linden
authors.affiliation: Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands. e.neefjes2@vumc.nl.
authors.forename: Elisabeth C W
authors.initials: EC
authors.lastname: Neefjes
authors.affiliation: Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, the Netherlands. h.verheul@vumc.nl.
authors.forename: Henk M W
authors.initials: HM
authors.lastname: Verheul
authors.affiliation: Department of Psychiatry and EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands. j.dekker@vumc.nl.|Department of Rehabilitation Medicine, VU University Medical Center, PO Box 7057, 1007MB, Amsterdam, the Netherlands. j.dekker@vumc.nl.
authors.forename: Joost
authors.initials: J
authors.lastname: Dekker
mesh_terms: D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D013315:Stress, Psychological / Q000175:diagnosis / Q000523:psychology* / Q000628:therapy*; D016896:Treatment Outcome