title: U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol.
abstract: BACKGROUND
  Approximately 20-30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment. This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinically relevant levels of anxiety and depression symptoms. This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community.
  
  
  METHODS
  Applying a multi-disciplinary and design-oriented approach aimed at attaining new evidence-based knowledge in basic and applied psychosocial oncology, this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient anxiety and depression. A prospective randomized design will be used.The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform. Another goal is to reduce costs for individuals and society, caused by emotional distress in response to cancer.Following screening to detect levels of patient distress, patients will be randomized to standard care or a stepped care intervention. For patients randomized to the intervention, step 1 will consist of self-help material, a chat forum where participants will be able to communicate with each other, and a Frequently Asked Questions (FAQ) section where they can ask questions and get answers from an expert. Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2, which will consist of cognitive behavioral therapy (CBT) administered by a personal therapist. The primary end point of the study is patients' levels of anxiety and depression, evaluated longitudinally during and after the intervention.
  
  
  CONCLUSIONS
  There is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders. Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited, there is a need to develop evidence-based stepped care for patients with cancer, to be delivered via the Internet.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01630681.
authors.affiliation: Department of Public Health and Caring Sciences, Uppsala University, Box 564, SE-751 22 Uppsala, Sweden. susanne.mattsson@pubcare.uu.se.
authors.forename: Susanne
authors.initials: S
authors.lastname: Mattsson
authors.forename: Sven
authors.initials: S
authors.lastname: Alfonsson
authors.forename: Maria
authors.initials: M
authors.lastname: Carlsson
authors.forename: Peter
authors.initials: P
authors.lastname: Nygren
authors.forename: Erik
authors.initials: E
authors.lastname: Olsson
authors.forename: Birgitta
authors.initials: B
authors.lastname: Johansson
mesh_terms: D001007:Anxiety / Q000209:etiology* / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003863:Depression / Q000209:etiology* / Q000628:therapy*; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000523:psychology; D011613:Psychotherapy
references.citation: Soc Sci Med. 2005 Jan;60(1):1-12
references.pmid: 15482862
references.citation: Br J Psychiatry. 2003 Jul;183:57-65
references.pmid: 12835245
references.citation: Qual Life Res. 2008 Feb;17(1):95-104
references.pmid: 18026852
references.citation: Cancer. 2003 Mar 1;97(5):1164-73
references.pmid: 12599221
references.citation: Eur J Health Econ. 2011 Oct;12(5):489-97
references.pmid: 20689977
references.citation: J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
references.pmid: 8433390
references.citation: Br J Cancer. 2007 Mar 26;96(6):868-74
references.pmid: 17311020
references.citation: Acta Psychiatr Scand. 1983 Jun;67(6):361-70
references.pmid: 6880820
references.citation: J Natl Cancer Inst. 2009 Nov 4;101(21):1464-88
references.pmid: 19826136
references.citation: Cancer Nurs. 2007 May-Jun;30(3):E10-9
references.pmid: 17510577
references.citation: Eur J Cancer. 2009 Nov;45(17):3017-26
references.pmid: 19765978
references.citation: Arch Gen Psychiatry. 2009 Mar;66(3):297-304
references.pmid: 19255379
references.citation: Psychol Med. 2010 Nov;40(11):1797-810
references.pmid: 20085667
references.citation: Psychol Med. 2007 Mar;37(3):319-28
references.pmid: 17112400
references.citation: Br J Cancer. 2010 Apr 27;102(9):1348-54
references.pmid: 20424614
references.citation: Am J Psychiatry. 2005 Jun;162(6):1158-64
references.pmid: 15930065
references.citation: Psychosom Med. 2006 Nov-Dec;68(6):870-8
references.pmid: 17079709
references.citation: J Psychosom Res. 2003 Sep;55(3):259-62
references.pmid: 12932800
references.citation: Gen Hosp Psychiatry. 2008 Mar-Apr;30(2):112-26
references.pmid: 18291293
references.citation: Eur J Cancer. 2008 Nov;44(16):2418-24
references.pmid: 18774706
references.citation: J Psychosom Res. 2002 Feb;52(2):69-77
references.pmid: 11832252
references.citation: Br J Psychiatry. 1979 Apr;134:382-9
references.pmid: 444788
references.citation: Psychooncology. 2011 Jun;20(6):655-63
references.pmid: 21381148
references.citation: Int J Geriatr Psychiatry. 2005 Jul;20(7):629-34
references.pmid: 16021666
references.citation: J Gen Intern Med. 2009 Nov;24 Suppl 2:S417-24
references.pmid: 19838842
references.citation: Health Qual Life Outcomes. 2007 Apr 11;5:18
references.pmid: 17428340
references.citation: J Clin Oncol. 1996 Oct;14(10):2756-68
references.pmid: 8874337
references.citation: Br J Cancer. 2011 Dec 6;105(12):1814-7
references.pmid: 22095232
references.citation: Br J Cancer. 2008 Dec 16;99(12):1975-83
references.pmid: 19018255
references.citation: J Affect Disord. 2001 May;64(2-3):203-16
references.pmid: 11313087
references.citation: Br J Psychiatry. 2005 Jan;186:11-7
references.pmid: 15630118
references.citation: Cochrane Database Syst Rev. 2005 Oct 19;(4):CD004274
references.pmid: 16235356
references.citation: Acta Psychiatr Scand. 1994 Jan;89(1):21-8
references.pmid: 8140903
references.citation: Psychooncology. 2003 Mar;12(2):183-93
references.pmid: 12619150
references.citation: Br J Cancer. 2004 Jun 14;90(12):2297-304
references.pmid: 15162149
references.citation: Acta Oncol. 2013 Jan;52(1):118-27
references.pmid: 22934559
references.citation: Health Qual Life Outcomes. 2008 Jul 02;6:46
references.pmid: 18597689
references.citation: Can J Psychiatry. 2006 Sep;51(10):662-70
references.pmid: 17052034
references.citation: Health Policy. 1990 Dec;16(3):199-208
references.pmid: 10109801
references.citation: Psychol Bull. 2008 Jan;134(1):1-30
references.pmid: 18193993
references.citation: Thorax. 2010 Apr;65(4):327-33
references.pmid: 20388758