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 |
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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
Plain English summary of protocol
Contact information
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 |
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michael.sharpe@ed.ac.uk |
Study information
Study design | Multicentre randomised controlled two-arm parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study acronym | SMaRT (Symptom Management Research Trials) |
Study objectives | 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(s) | Scotland A research ethics committee, 31/03/2008, ref: 08/MRE00/23 |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Treatment response, measured at 24 week outcome data collection, defined as a reduction of 50% or more in the patients 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 study start date | 15/05/2008 |
Completion date | 01/06/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 500 |
Total final enrolment | 500 |
Key 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 |
Key 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. |
Date of first enrolment | 15/05/2008 |
Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
EH10 5HF
United Kingdom
Sponsor information
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 |
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marise.bucukoglu@ed.ac.uk | |
Website | http://www.ed.ac.uk/ |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
Research & Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
United Kingdom
Funders
Funder type
Charity
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.