Multi-component nurse delivered intervention for major depressive disorder in patients with cancer

ISRCTN	ISRCTN84767225
DOI	https://doi.org/10.1186/ISRCTN84767225
Protocol serial number	N/A
Sponsor	University of Edinburgh (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C5547/A5576)

Submission date: 22/08/2005
Registration date: 15/09/2005
Last edited: 18/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Michael Sharpe
Scientific

University of Edinburgh
Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom

Phone	+44 (0)131 537 6672
Email	michael.sharpe@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SMaRT oncology 1
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer and depression
Intervention	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 patients GP.
Intervention type	Other
Primary outcome measure(s)	The principal outcome measure will be a 50% reduction in the SCL-20 depressive symptoms score from baseline.
Key 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
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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.
Date of first enrolment	06/10/2003
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

University of Edinburgh

Edinburgh
EH10 5HF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/07/2008		Yes	No
Other publications	preliminary analysis	26/01/2004		Yes	No