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

ISRCTN ISRCTN40568538
DOI https://doi.org/10.1186/ISRCTN40568538
Secondary identifying numbers v1.1 12/05/08
Submission date
13/05/2008
Registration date
30/05/2008
Last edited
04/04/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-treating-depression-people-with-cancer-smart-oncology-2

Contact information

Prof Michael Sharpe
Scientific

School of Molecular and Clinical Medicine
The University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
Morningside Park
Edinburgh
EH10 5HF
United Kingdom

Phone +44 (0)131 537 6672
Email michael.sharpe@ed.ac.uk

Study information

Study designMulticentre randomised controlled two-arm parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSMaRT 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
Study acronymSMaRT (Symptom Management Research Trials)
Study objectives1. '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(s)Scotland A research ethics committee, 31/03/2008, ref: 08/MRE00/23
Health condition(s) or problem(s) studiedDepression in patients with cancer
InterventionPatients 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 typeOther
Primary outcome measureTreatment 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 measures1. 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 study start date15/05/2008
Completion date01/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Total final enrolment500
Key inclusion criteriaPatients 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
Key exclusion criteria1. 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.
Date of first enrolment15/05/2008
Date of final enrolment01/06/2011

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

The University of Edinburgh
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

University of Edinburgh
University/education

c/o Marise Bucukoglu
Associate Director (Governance & Sponsorship)
Edinburgh Clinical Trials Unit
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone +44 (0)131 242 9262
Email marise.bucukoglu@ed.ac.uk
Website http://www.ed.ac.uk/
ROR logo "ROR" https://ror.org/01nrxwf90
NHS Lothian - University Hospitals Division (UK)
Hospital/treatment centre

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

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 30/03/2009 Yes No
Results article results 20/09/2014 Yes No
Results article results 01/12/2015 Yes No
Plain English results 04/04/2022 No Yes

Editorial Notes

04/04/2022: Plain English results and total final enrolment added.
20/07/2016: Publication references added.