Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Michael Sharpe


Contact details

Psychological Medicine & Symptoms Research Group
School of Molecular & Clinical Medicine
University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
EH10 5HF
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


SMaRT 3 Pilot

Study hypothesis

A pilot trial to:
1: Test the feasibility and acceptability of procedures
2: Obtain data to inform the sample size calculation for the SMaRT Oncology-3 Trial

SMaRT Oncology-3 Trial: A two-arm parallel group randomised controlled trial to determine the efficacy of adding a multi-component intervention for major depressive disorder to usual care compared to usual care alone in cancer patients who have a limited life expectancy.

Ethics approval

Lothian Local Research Ethics Committee approval granted on 13 September 2007 (ref: 07/S1104/33)

Study design

A two-arm parallel group randomised controlled pilot trial.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cancer, major depressive disorder


Usual care:
The patients' general practitioner and oncologist will be informed of their diagnosis of MDD. Patients will then receive the usual clinical management of depression as currently practised.

Usual care supplemented with "Depression Care for People with Cancer":
In addition to the above Depression Care for People with Cancer will be implemented.

Components of Depression Care for People with Cancer:
1. Coordination of depression care and provision of information to all relevant health professionals
2. Brief psychological intervention for a maximum of ten sessions over a three-month period including education about depression and its management (behavioural activation and antidepressant medication) and problem-solving training
3. Monthly active follow-up by telephone for a further three-month period
4. Advice to general practitioner regarding the prescription of antidepressant medication

Intervention type



Not Specified

Drug names

Primary outcome measure

Acceptability and feasibility of the trial procedures

Secondary outcome measures

The following data will be collected at baseline, 4, 8, 12, 16, 20 and 24 weeks:
1. Hopkin's Symptom Checklist Depression Scale (SCL-20)
2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30
3. EuroQuol-5D
4. Satisfaction with depression care item

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Have a diagnosis of cancer
2. Be aged 18 or over
3. Be under specialist oncology care
4. Have a predicted survival, estimated by their cancer specialist, of between three and twelve months
5. Have symptoms which meet the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for Major Depressive Disorder (MDD) (using the inclusive approach to diagnosis)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unable to provide informed consent to participate
2. Episode of MDD is chronic (defined as a history of continuous depression for at least two years)
3. Judged to require urgent psychiatric care
4. Receiving active psychiatric or psychological treatment from specialist mental health services
5. Cognitive impairment or communication difficulties which are incompatible with the intervention
6. Known cerebral metastases
7. Unable to attend regularly for treatment sessions
8. Intervention is judged to be inappropriate due to a medical condition which requires alternative treatment
9. Intervention is judged to be inappropriate due to a psychiatric condition which requires alternative treatment (psychotic illness, bipolar affective disorder, obsessive compulsive disorder, substance abuse or dependence)
10. Participation in the trial is judged to be inappropriate on clinical grounds

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine & Symptoms Research Group
EH10 5HF
United Kingdom

Sponsor information


University of Edinburgh, Lothian Health Board, University Hospitals Division (UK)

Sponsor details

c/o Dr Marise Bucukoglu
Clinical Trials and Research Governance Manager
College of Medicines and Veterinary Medicine
The Queen's Medical Research Institute
EH16 4TJ
United Kingdom
+44 (0)131 242 9262

Sponsor type




Funder type


Funder name

Cancer Research UK (ref: C5547/A7375)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


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

Basic results (scientific)

Publication list

1. 2009 results in

Publication citations

  1. Results

    Walker J, Sharpe M, Depression Care for People with Cancer: a collaborative care intervention., Gen Hosp Psychiatry, 31, 5, 436-441, doi: 10.1016/j.genhosppsych.2009.05.010.

Additional files

Editorial Notes