Condition category
Mental and Behavioural Disorders
Date applied
22/08/2005
Date assigned
15/09/2005
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Sharpe

ORCID ID

Contact details

University of Edinburgh
Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
+44 (0)131 537 6672
michael.sharpe@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SMaRT oncology 1

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 patient’s GP.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The principal outcome measure will be a 50% reduction in the SCL-20 depressive symptoms score from baseline.

Secondary outcome measures

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

Overall trial start date

06/10/2003

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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.

Recruitment start date

06/10/2003

Recruitment end date

30/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Edinburgh
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9253
paul.mcguire@ed.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C5547/A5576)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Preliminary analysis

    Sharpe M, Strong V, Allen K, Rush R, Maguire P, House A, Ramirez A, Cull A, Management of major depression in outpatients attending a cancer centre: a preliminary evaluation of a multicomponent cancer nurse-delivered intervention., Br. J. Cancer, 2004, 90, 2, 310-313, doi: 10.1038/sj.bjc.6601546.

  2. Results

    Strong V, Waters R, Hibberd C, Murray G, Wall L, Walker J, McHugh G, Walker A, Sharpe M, Management of depression for people with cancer (SMaRT oncology 1): a randomised trial., Lancet, 2008, 372, 9632, 40-48, doi: 10.1016/S0140-6736(08)60991-5.

Additional files

Editorial Notes