Multi-component nurse delivered intervention for major depressive disorder in patients with cancer
| ISRCTN | ISRCTN84767225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84767225 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/08/2005
- Registration date
- 15/09/2005
- Last edited
- 18/01/2012
- 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
Not provided at time of registration
Contact information
Prof Michael Sharpe
Scientific
Scientific
University of Edinburgh
Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
| Phone | +44 (0)131 537 6672 |
|---|---|
| michael.sharpe@ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SMaRT oncology 1 |
| Study objectives | The supplementation of optimised usual care with a nurse delivered multifactorial intervention will be effective and more cost-effective than usual care alone in relieving major depressive disorder in patients attending an oncology outpatient clinic with a diagnosis of cancer and comorbid major depression. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer and depression |
| Intervention | Both groups will receive optimised usual care i.e. current practice in the Edinburgh Cancer Centre. In addition, the GP and Oncologist will be informed that the patient has major depression and asked to manage their care as normal. General guidance on the management of major depression will be given. A minority may be referred to specialist services. One group will, in addition, receive a nurse-delivered psychiatrist-supervised multi-component intervention. This intervention is based upon a case-management approach. It aims to empower the patient in taking an active approach to the management of their depressive disorder and includes both training in advanced coping skills and antidepressant medication as prescribed by the patients GP. |
| Intervention type | Other |
| Primary outcome measure | The principal outcome measure will be a 50% reduction in the SCL-20 depressive symptoms score from baseline. |
| Secondary outcome measures | Secondary measures will be: 1. Mean depression scores from the SCL-20 2. Remission specified as an SCL-20 score of <0.75 3. The presence of major depressive disorder assessed by SCID diagnostic interview Subsidiary outcome measures will be: 1. Quality of life measured on the World Health Organisation (WHO) EQ-5D 2. EORTC-QLQ-C30 3. Anxiety measured on the 10 anxiety items of the SCL-90 4. A measure of self-efficacy, coping and social support 5. An estimate of the direct health care costs measured by case note review and patient questionnaire The outcomes will be measured at 3, 6 and 12 months |
| Overall study start date | 06/10/2003 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Patients attending Edinburgh Cancer Centre identified through a screening process or by referral and noted to have: 1. Definite or probable major depressive disorder on Structured Clinical Interview for Depression (SCID) interview 2. SCL-20 depression score of at least 1.72 3. A diagnosis of cancer |
| Key exclusion criteria | Predicted survival less than 6 months; another complicating and uncontrolled medical problem or where antidepressants are contraindicated; too ill to participate in treatment due to ongoing cancer therapy; complicating major psychiatric diagnosis or an alcohol or substance misuse problem; chronic depression; under active treatment for their depression; judged to be in need of urgent psychiatric treatment; unable to communicate adequately due to language problems or cognitive impairment; unable to travel to centre for treatment. |
| Date of first enrolment | 06/10/2003 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Edinburgh
Edinburgh
EH10 5HF
United Kingdom
EH10 5HF
United Kingdom
Sponsor information
University of Edinburgh (UK)
University/education
University/education
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 9253 |
|---|---|
| paul.mcguire@ed.ac.uk | |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C5547/A5576)
Private sector organisation / Other non-profit organizations
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 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | preliminary analysis | 26/01/2004 | Yes | No | |
| Results article | results | 05/07/2008 | Yes | No |
