Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Prof Michael Sharpe


Contact details

School of Molecular and Clinical Medicine
The University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
EH10 5HF
United Kingdom
+44 (0)131 537 6672

Additional identifiers

EudraCT number number

Protocol/serial number

v1.0 25.09.08

Study information

Scientific title

SMaRT Oncology-3: a two-arm parallel group randomised controlled trial to determine the efficacy of adding a complex intervention for major depressive disorder ("Depression Care for People with Lung Cancer") to usual care, compared to usual care alone in patients with lung cancer


SMaRT (Symptom Management Research Trials)

Study hypothesis

Supplementing usual care with "Depression Care for People with Lung Cancer" will improve the following over eight months (32 weeks):
1. Depressive symptoms
2. Other symptoms (pain, fatigue, anxiety)
3. Functioning
4. Quality of life
5. Satisfaction with depression care

The pilot study for this trial can be found on the ISRCTN Register under ISRCTN16242820. In addition to this, a related trial SMaRT Oncology-2 is can also be found on the ISRCTN Register under ISRCTN40568538.

Ethics approval

Scotland A Research Ethics Committee on 23/10/2008 (ref: 08/MRE00/95)

Study design

Two-arm parallel-group randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Depression in patients with cancer


Patients will be randomised to receive 'usual care' or 'usual care' plus "Depression Care for People with Lung Cancer". "Depression Care for People with Lung Cancer" is a complex intervention which includes education on depression and its treatments, and a problem solving treatment. It is delivered by specially trained cancer nurses supervised by psychiatrists. A maximum of 10 sessions over 16 weeks will be given, followed by monthly follow-up telephone conversations for a further 4 months. Sessions last 30 minutes to 1 hour.

Details of Joint Sponsor:
NHS Lothian - University Hospitals Division (UK)
Research and Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh EH16 4SA
United Kingdom

Intervention type



Not Applicable

Drug names

Primary outcome measures

Average depression severity, assessed using Symptom Checklist (SCL)-20D scores, collected every four weeks over 32 weeks.

Secondary outcome measures

The following will be assessed every four weeks over 32 weeks:
1. Severity of anxiety symptoms, measured by the Symptom Checklist (SCL)-10A
2. Severity of pain and fatigue, measured by the relevant symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30)
3. Physical, social and role functioning, and overall health and quality of life measured by the relevant scales of the EORTC QLQ-C30
4. Patient's satisfaction with depression care, measured by a 5-point Likert scale item developed specifically for the trial

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Both males and females, aged 18 or over
2. Have a diagnosis of lung cancer
3. Have a predicted survival, estimated by their cancer specialist, of three months or more
4. Have symptoms which meet the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for major depressive disorder (MDD), with symptoms of the current major depressive episode (MDE) present for four weeks or more 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. The episode of depression 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 (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention
6. Known cerebral metastases
7. Unable to participate regularly in treatment sessions
8. The intervention is judged to be inappropriate due to a medical condition which requires alternative treatment
9. The 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 other clinical grounds

N.B. Patients receiving active cancer treatments will not be excluded unless they fulfil one or more of the exclusion criteria listed above.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

School of Molecular and Clinical Medicine
EH10 5HF
United Kingdom

Sponsor information


University of Edinburgh (UK)

Sponsor details

c/o Marise Bucukoglu
Edinburgh Clinical Trials Unit
Western General Hospital
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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

2009 protocol in:
2014 results in:

Publication citations

  1. Protocol

    Walker J, Cassidy J, Sharpe M, , The third symptom management research trial in oncology (SMaRT oncology-3): a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (depression care for people with lung cancer) to usual care, compared to usual care alone in patients with lung cancer., Trials, 2009, 10, 92, doi: 10.1186/1745-6215-10-92.

  2. Results

    Walker J, Hansen CH, Martin P, Symeonides S, Gourley C, Wall L, Weller D, Murray G, Sharpe M; SMaRT (Symptom Management Research Trials) Oncology-3 Team, Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer, Lancet Oncol, 2014, 15, 10, 1168-1176, doi: 10.1016/S1470-2045(14)70343-2.

Additional files

Editorial Notes