|
Welcome
|
|
12 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
|
| [ ...Back to search results ] | [ Print-friendly version ] |
| Better management of depression in cancer / Symptom Management Research Trials 3 Pilot |
| Source of record | UK Trials |
| ISRCTN | ISRCTN16242820 |
| Date ISRCTN assigned | 13/12/2007 |
| Local reference number(s) | NA |
| Public title | Better management of depression in cancer / Symptom Management Research Trials 3 Pilot |
| Scientific title | |
| Acronym | SMaRT 3 Pilot |
| Disease/condition/study domain | Cancer, major depressive disorder |
| Study hypothesis | A pilot trial to: 1: Test the feasibility and acceptability of procedures 2: Obtain data to inform the sample size calculation for the SMaRT Oncology-3 Trial SMaRT Oncology-3 Trial: A two-arm parallel group randomised controlled trial to determine the efficacy of adding a multi-component intervention for major depressive disorder to usual care compared to usual care alone in cancer patients who have a limited life expectancy. |
| Design/methodology | A two-arm parallel group randomised controlled pilot trial. |
| Research ethics review | Lothian Local Research Ethics Committee approval granted on 13 September 2007 (ref: 07/S1104/33) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Have a diagnosis of cancer 2. Be aged 18 or over 3. Be under specialist oncology care 4. Have a predicted survival, estimated by their cancer specialist, of between three and twelve months 5. Have symptoms which meet the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for Major Depressive Disorder (MDD) (using the inclusive approach to diagnosis) |
| Participants - exclusion criteria | 1. Unable to provide informed consent to participate 2. Episode of MDD 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 which are incompatible with the intervention 6. Known cerebral metastases 7. Unable to attend regularly for treatment sessions 8. Intervention is judged to be inappropriate due to a medical condition which requires alternative treatment 9. 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 clinical grounds |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 03/12/2007 |
| Anticipated end date | 28/02/2008 |
| Status of trial | Completed |
| Target number of participants | 10-20 |
| Interventions | Usual care: The patients' general practitioner and oncologist will be informed of their diagnosis of MDD. Patients will then receive the usual clinical management of depression as currently practised. Usual care supplemented with "Depression Care for People with Cancer": In addition to the above Depression Care for People with Cancer will be implemented. Components of Depression Care for People with Cancer: 1. Coordination of depression care and provision of information to all relevant health professionals 2. Brief psychological intervention for a maximum of ten sessions over a three-month period including education about depression and its management (behavioural activation and antidepressant medication) and problem-solving training 3. Monthly active follow-up by telephone for a further three-month period 4. Advice to general practitioner regarding the prescription of antidepressant medication |
| Primary outcome measure(s) | Acceptability and feasibility of the trial procedures |
| Secondary outcome measure(s) | The following data will be collected at baseline, 4, 8, 12, 16, 20 and 24 weeks: 1. Hopkin's Symptom Checklist Depression Scale (SCL-20) 2. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 3. EuroQuol-5D 4. Satisfaction with depression care item |
| Sources of funding | Cancer Research UK (ref: C5547/A7375) |
| Sponsor name | University of Edinburgh, Lothian Health Board, University Hospitals Division (UK) |
| Sponsor details | c/o Dr Marise Bucukoglu Clinical Trials and Research Governance Manager College of Medicines and Veterinary Medicine The Queen's Medical Research Institute Edinburgh United Kingdom EH16 4TJ |
| Sponsor telephone | +44 (0)131 242 9262 |
| Sponsor email | mbrown11@miscorp.ed.ac.uk |
| Sponsor website | http://www.ed.ac.uk/ |
| Contact name | Prof Michael Sharpe |
| Contact details | Psychological Medicine & Symptoms Research Group School of Molecular & Clinical Medicine University of Edinburgh Kennedy Tower Royal Edinburgh Hospital Edinburgh United Kingdom EH10 5HF |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN16242820 |
| Date last extracted from ISRCTN register | 17/04/2008 |
|
|
|
|
|
| © 2012 Current Controlled Trials Ltd. Part of Springer Science+Business Media. | terms & conditions | privacy statement | |
|
|
|
|