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Multi-component nurse delivered intervention for major depressive disorder in patients with cancer
ISRCTN ISRCTN84767225
DOI 10.1186/ISRCTN84767225
ClinicalTrials.gov identifier
EudraCT number
Public title Multi-component nurse delivered intervention for major depressive disorder in patients with cancer
Scientific title
Acronym SMaRT oncology 1
Serial number at source N/A
Study hypothesis The supplementation of optimised usual care with a nurse delivered multifactorial intervention will be effective and more cost-effective than usual care alone in relieving major depressive disorder in patients attending an oncology outpatient clinic with a diagnosis of cancer and comorbid major depression.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cancer and depression
Participants - inclusion criteria Patients attending Edinburgh Cancer Centre identified through a screening process or by referral and noted to have:
1. Definite or probable major depressive disorder on Structured Clinical Interview for Depression (SCID) interview
2. SCL-20 depression score of at least 1.72
3. A diagnosis of cancer
Participants - exclusion criteria Predicted survival less than 6 months; another complicating and uncontrolled medical problem or where antidepressants are contraindicated; too ill to participate in treatment due to ongoing cancer therapy; complicating major psychiatric diagnosis or an alcohol or substance misuse problem; chronic depression; under active treatment for their depression; judged to be in need of urgent psychiatric treatment; unable to communicate adequately due to language problems or cognitive impairment; unable to travel to centre for treatment.
Anticipated start date 06/10/2003
Anticipated end date 30/06/2006
Status of trial Completed
Patient information material
Target number of participants 200
Interventions Both groups will receive optimised usual care i.e. current practice in the Edinburgh Cancer Centre. In addition, the GP and Oncologist will be informed that the patient has major depression and asked to manage their care as normal. General guidance on the management of major depression will be given. A minority may be referred to specialist services. One group will, in addition, receive a nurse-delivered psychiatrist-supervised multi-component intervention. This intervention is based upon a case-management approach. It aims to empower the patient in taking an active approach to the management of their depressive disorder and includes both training in advanced coping skills and antidepressant medication as prescribed by the patientís GP.
Primary outcome measure(s) The principal outcome measure will be a 50% reduction in the SCL-20 depressive symptoms score from baseline.
Secondary outcome measure(s) Secondary measures will be:
1. Mean depression scores from the SCL-20
2. Remission specified as an SCL-20 score of <0.75
3. The presence of major depressive disorder assessed by SCID diagnostic interview

Subsidiary outcome measures will be:
1. Quality of life measured on the World Health Organisation (WHO) EQ-5D
2. EORTC-QLQ-C30
3. Anxiety measured on the 10 anxiety items of the SCL-90
4. A measure of self-efficacy, coping and social support
5. An estimate of the direct health care costs measured by case note review and patient questionnaire

The outcomes will be measured at 3, 6 and 12 months
Sources of funding Cancer Research UK (CRUK) (UK) (ref: C5547/A5576)
Trial website
Publications 1. 2004 preliminary analysis in http://www.ncbi.nlm.nih.gov/pubmed/14735169
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18603157
Contact name Prof  Michael  Sharpe
  Address University of Edinburgh
Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
  City/town Edinburgh
  Zip/Postcode EH10 5HF
  Country United Kingdom
  Tel +44 (0)131 537 6672
  Fax +44 (0)131 537 6641
  Email michael.sharpe@ed.ac.uk
Sponsor University of Edinburgh (UK)
  Address Queen's Medical Research Institute
47 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4TJ
  Country United Kingdom
  Tel +44 (0)131 242 9253
  Email paul.mcguire@ed.ac.uk
Date applied 22/08/2005
Last edited 18/01/2012
Date ISRCTN assigned 15/09/2005
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