Better management of depression in cancer / Symptom Management Research Trials 3 Pilot
| ISRCTN | ISRCTN16242820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16242820 |
| Protocol serial number | NA |
| Sponsor | University of Edinburgh, Lothian Health Board, University Hospitals Division (UK) |
| Funder | Cancer Research UK (ref: C5547/A7375) |
- Submission date
- 27/11/2007
- Registration date
- 13/12/2007
- Last edited
- 01/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Sharpe
Scientific
Scientific
Psychological Medicine & Symptoms Research Group
School of Molecular & Clinical Medicine
University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A two-arm parallel group randomised controlled pilot trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | SMaRT 3 Pilot |
| Study objectives | 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. |
| Ethics approval(s) | Lothian Local Research Ethics Committee approval granted on 13 September 2007 (ref: 07/S1104/33) |
| Health condition(s) or problem(s) studied | Cancer, major depressive disorder |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
Acceptability and feasibility of the trial procedures |
| Key secondary outcome measure(s) |
The following data will be collected at baseline, 4, 8, 12, 16, 20 and 24 weeks: |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 03/12/2007 |
| Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Psychological Medicine & Symptoms Research Group
Edinburgh
EH10 5HF
United Kingdom
EH10 5HF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
