Condition category
Mental and Behavioural Disorders
Date applied
13/05/2008
Date assigned
30/05/2008
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively 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
Morningside Park
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

v1.1 12/05/08

Study information

Scientific title

SMaRT oncology-2: a two arm parallel group randomised controlled trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder ('Depression Care for People with Cancer') to usual care, compared to usual care alone in cancer patients

Acronym

SMaRT (Symptom Management Research Trials)

Study hypothesis

1. 'Depression Care for People with Cancer' as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline 20-item depression score from the Symptoms Checklist (SCL-20D) at 24 weeks
2. 'Depression Care for People with Cancer' as a supplement to usual care will cost more than usual care alone but will be more cost effective in achieving improvements in patients’ depression and quality of life

Ethics approval

Scotland A research ethics committee, 31/03/2008, ref: 08/MRE00/23

Study design

Multicentre randomised controlled two-arm parallel-group 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:
1. Usual care, or
2. Usual care plus 'Depression Care for People with Cancer'

Usual care arm:
The usual care of depression from the patient's GP or oncologist (this is routine care and won't be influenced by the researchers)

Usual care plus 'Depression Care for People with Cancer' arm:
In addition to usual care as above a complex intervention for depression delivered by a specially trained cancer nurse under the supervision of a psychiatrist, a maximum of 10 treatment sessions delivered over 16 weeks followed by monthly monitoring of progress until 12 months. The intervention comprises education about depression and its treatments (including antidepressant medication, which would be prescribed by the GP if the patient wishes to take it, and behavioural activation) and problem solving treatment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Treatment response, measured at 24 week outcome data collection, defined as a reduction of 50% or more in the patient’s baseline SCL-20D score

Secondary outcome measures

1. Remission of major depressive disorder, defined as an SCL-20D score of less than 0.75 at each of 24, 36 and 48 weeks (higher than in primary care trials, to allow for cancer-related somatic symptoms)
2. Depression severity, defined for each patient as the average of their SCL-20D score at 24, 36 and 48 weeks

Overall trial start date

15/05/2008

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients must:
1. Have a diagnosis of cancer, with active disease within the last five years
2. Be aged 18 or over, either sex
3. Be attending a specialist oncology clinic
4. Have a predicted survival, estimated by their cancer specialist, of twelve months or more
5. Have symptoms that meet 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

500

Participant exclusion criteria

1. Patients are 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. They are judged to require urgent psychiatric care
4. They are receiving active psychiatric or psychological treatment from specialist mental health services
5. They have cognitive impairment or communication difficulties (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention
6. They have known cerebral metastases
7. They are unable to attend regularly for 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. Their 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

15/05/2008

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Edinburgh
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

c/o Marise Bucukoglu
Associate Director (Governance & Sponsorship)
Edinburgh Clinical Trials Unit
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9262
marise.bucukoglu@ed.ac.uk

Sponsor type

University/education

Website

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

Organisation

NHS Lothian - University Hospitals Division (UK)

Sponsor details

Research & Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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/19331675
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25175478
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26652589

Publication citations

  1. Protocol

    Walker J, Cassidy J, Sharpe M, , The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients., Trials, 2009, 10, 18, doi: 10.1186/1745-6215-10-18.

  2. Results

    Sharpe M, Walker J, Holm Hansen C, Martin P, Symeonides S, Gourley C, Wall L, Weller D, Murray G; SMaRT (Symptom Management Research Trials) Oncology-2 Team, Integrated collaborative care for comorbid major depression in patients with cancer (SMaRT Oncology-2): a multicentre randomised controlled effectiveness trial, Lancet, 2014, 384, 9948, 1099-1108, doi: 10.1016/S0140-6736(14)61231-9.

  3. Results

    Duarte A, Walker J, Walker S, Richardson G, Holm Hansen C, Martin P, Murray G, Sculpher M, Sharpe M, Cost-effectiveness of integrated collaborative care for comorbid major depression in patients with cancer, J Psychosom Res, 2015 , 79, 6, 465-470, doi: 10.1016/j.jpsychores.2015.10.012.

Additional files

Editorial Notes

20/07/2016: Publication references added.