Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NA
Study information
Scientific title
Acronym
SMaRT 3 Pilot
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.
Ethics approval
Lothian Local Research Ethics Committee approval granted on 13 September 2007 (ref: 07/S1104/33)
Study design
A two-arm parallel group randomised controlled pilot trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Acceptability and feasibility of the trial procedures
Secondary outcome measures
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
Overall trial start date
03/12/2007
Overall trial end date
28/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10-20
Participant 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
Recruitment start date
03/12/2007
Recruitment end date
28/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychological Medicine & Symptoms Research Group
Edinburgh
EH10 5HF
United Kingdom
Sponsor information
Organisation
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
EH16 4TJ
United Kingdom
+44 (0)131 242 9262
mbrown11@miscorp.ed.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (ref: C5547/A7375)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19703637
Publication citations
-
Results
Walker J, Sharpe M, Depression Care for People with Cancer: a collaborative care intervention., Gen Hosp Psychiatry, 31, 5, 436-441, doi: 10.1016/j.genhosppsych.2009.05.010.