Condition category
Mental and Behavioural Disorders
Date applied
18/11/2008
Date assigned
28/11/2008
Last edited
15/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Michael Sharpe

ORCID ID

Contact details

School of Molecular and Clinical Medicine
The University of Edinburgh
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

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Depression in patients with cancer

Intervention

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

Other

Phase

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

01/12/2008

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

200

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

01/12/2008

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Molecular and Clinical Medicine
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

c/o Marise Bucukoglu
Edinburgh Clinical Trials Unit
Western General Hospital
Edinburgh
EH4 2XR
United Kingdom
-
marise.bucukoglu@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19793390
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25175097

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