title: The effectiveness of a nurse-led intervention with the distress thermometer for patients treated with curative intent for breast cancer: design of a randomized controlled trial.
abstract: Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT on the psychosocial wellbeing of the patient are unknown. A study to assess the psychosocial consequences of the systematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer is needed.
  
  
  
  The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded randomized controlled trial. Patients treated with curative intent for breast cancer will be recruited from the Radboud University Medical Center. The intervention consists of the DT together with discussion of the results with the patient by a trained oncology nurse added to the usual care. Patients will be randomly allocated (1:1) to either receive usual care or the usual care plus the intervention. Primary outcome measure is global quality of life measured with the EORTC QLQ-C30. The functional and symptom scales of the EORTC QLQ-C30 and BR23, Hospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline and final measurement only) will be used to measure secondary outcomes. Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three and six months' interval during the first and second year respectively.
  
  
  
  This study will be the first randomized controlled longitudinal study about the effectiveness of the DT as nurse led-intervention. In case of proven effectiveness, future implementation and standardization of use of the DT as part of routine care will be recommended.
  
  
  
  This study is registered at clinicaltrial.gov march 17, 2010 ( NCT01091584 ).
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, 6500, Nijmegen, The Netherlands. floor.ploosvanamstel@radboudumc.nl.
authors.forename: Floortje K
authors.initials: FK
authors.lastname: Ploos van Amstel
authors.affiliation: Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Judith B
authors.initials: JB
authors.lastname: Prins
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, 6500, Nijmegen, The Netherlands.|Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, UK.
authors.forename: Winette T A
authors.initials: WT
authors.lastname: van der Graaf
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, 6500, Nijmegen, The Netherlands.
authors.forename: Marlies E W J
authors.initials: ME
authors.lastname: Peters
authors.affiliation: Department of Medical Oncology, Radboud University Medical Center, P.O. Box 9101, 6500, Nijmegen, The Netherlands.
authors.forename: Petronella B
authors.initials: PB
authors.lastname: Ottevanger
mesh_terms: D001943:Breast Neoplasms / Q000523:psychology* / Q000628:therapy; D005260:Female; D006801:Humans; D009726:Nurses; D011581:Psychological Tests; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis* / Q000628:therapy
keywords: Breast cancer; Distress; Distress thermometer; Nurse; Nurse-led intervention; Oncology nurse; Psychosocial care; Quality of life; RCT; Screening