title: Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial.
abstract: BACKGROUND
  High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine, resulting in severe undertreatment of mental health problems in this patient group. Screening tools can be used to increase case identification, however, screening alone does not necessarily translate into better mental health for the patient. Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals. This study investigates whether a stepped care model, combining screening, doctor consultation and professional psycho-oncological service in a structured way, improves the emotional wellbeing of cancer patients.
  
  
  METHODS
  This study is a cluster randomized trial with two parallel groups (intervention vs. care as usual), set in an academic hospital. Participants are cancer patients, a total of 1,000 at baseline. The intervention consists of stepped psychosocial care. Step one: screening for distress, step two: feedback of screening results to the doctor in charge of the patient and consultation with the patient, and step three: based on a shared patient-doctor decision, either transferal to the consultation liaison (CL) service or not. The outcome will be emotional well-being half a year after baseline, ascertained with the Hospital Anxiety and Depression Scale. Randomization will be done by the cluster randomization of wards.
  
  
  CONCLUSIONS
  Mental health problems not only cause emotional suffering but also direct and indirect costs. This calls for timely and adequate psychosocial support, especially as we know that such support is effective. However, not every cancer patient can and must be treated by a mental health professional. Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible. It is the hope of the STEPPED CARE trial that this model is both effective and efficient, and that it can be implemented in other hospitals as well, if proven to be effective.
  
  
  BACKGROUND
  Clinical Trials Register (Clinicaltrials.gov) identifier: NCT01859429 registration date 17 May 2013.
authors.affiliation: Institute of Medical Biostatistics, Epidemiology, and Informatics (IMBEI), Division of Epidemiology and Health Services Research, University Medical Center Mainz, Obere Zahlbacher Straße 69, 55131 Mainz, Germany. singers@uni-mainz.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Singer
authors.forename: Helge
authors.initials: H
authors.lastname: Danker
authors.forename: Susanne
authors.initials: S
authors.lastname: Briest
authors.forename: Arne
authors.initials: A
authors.lastname: Dietrich
authors.forename: Andreas
authors.initials: A
authors.lastname: Dietz
authors.forename: Jens
authors.initials: J
authors.lastname: Einenkel
authors.forename: Kirsten
authors.initials: K
authors.lastname: Papsdorf
authors.forename: Florian
authors.initials: F
authors.lastname: Lordick
authors.forename: Jürgen
authors.initials: J
authors.lastname: Meixensberger
authors.forename: Joachim
authors.initials: J
authors.lastname: Mössner
authors.forename: Dietger
authors.initials: D
authors.lastname: Niederwieser
authors.forename: Torsten
authors.initials: T
authors.lastname: Prietzel
authors.forename: Franziska
authors.initials: F
authors.lastname: Schiefke
authors.forename: Jens-Uwe
authors.initials: JU
authors.lastname: Stolzenburg
authors.forename: Hubert
authors.initials: H
authors.lastname: Wirtz
authors.forename: Anette
authors.initials: A
authors.lastname: Kersting
mesh_terms: D000046:Academic Medical Centers; D001291:Attitude of Health Personnel; D002985:Clinical Protocols; D003142:Communication; D005858:Germany; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008603:Mental Health; D008605:Mental Health Services; D009369:Neoplasms / Q000150:complications / Q000175:diagnosis / Q000523:psychology*; D010358:Patient Participation; D010817:Physician-Patient Relations; D010820:Physicians / Q000523:psychology; D011237:Predictive Value of Tests; D011379:Prognosis; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012017:Referral and Consultation; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis* / Q000209:etiology / Q000523:psychology / Q000628:therapy; D011795:Surveys and Questionnaires; D013997:Time Factors