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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public 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 |
| Scientific title | |
| Acronym | SMaRT (Symptom Management Research Trials) |
| Serial number at source | v1.1 12/05/08 |
| 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 | Ethics approval received from the Scotland A research ethics committee on the 31st March 2008 (ref: 08/MRE00/23). |
| Study design | Two-arm parallel group randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Depression in patients with cancer |
| Participants - inclusion criteria |
To be included in the trial 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 |
| Participants - exclusion criteria |
Patients will be excluded if:
1. They 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. |
| Anticipated start date | 15/05/2008 |
| Anticipated end date | 01/06/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 500 |
| Interventions |
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. Co-sponsor of this trial: NHS Lothian - University Hospitals Division (UK) Research & Development Office Royal Infirmary of Edinburgh 51 Little France Crescent Edinburgh EH16 4SA United Kingdom |
| Primary outcome measure(s) | The primary outcome measure is treatment response, measured at 24 week outcome data collection. Treatment response will be defined as a reduction of 50% or more in the patient’s baseline SCL-20D score. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Cancer Research UK (CRUK) (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Michael Sharpe |
| Address |
School of Molecular and Clinical Medicine
The University of Edinburgh Kennedy Tower Royal Edinburgh Hospital Morningside Park |
| City/town | Edinburgh |
| Zip/Postcode | EH10 5HF |
| Country | United Kingdom |
| Tel | +44 (0)131 537 6672 |
| michael.sharpe@ed.ac.uk | |
| Sponsor | University of Edinburgh (UK) |
| Address |
c/o Marise Bucukoglu
Associate Director (Governance & Sponsorship) Edinburgh Clinical Trials Unit Queens Medical Research Institute 47 Little France Crescent |
| City/town | Edinburgh |
| Zip/Postcode | EH16 4TJ |
| Country | United Kingdom |
| Tel | +44 (0)131 242 9262 |
| marise.bucukoglu@ed.ac.uk | |
| Sponsor website: | http://www.ed.ac.uk/ |
| Date applied | 13/05/2008 |
| Last edited | 30/05/2008 |
| Date ISRCTN assigned | 30/05/2008 |
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