Better management of depression in cancer / Symptom Management Research Trials 3 Pilot

ISRCTN	ISRCTN16242820
DOI	https://doi.org/10.1186/ISRCTN16242820
Secondary identifying numbers	NA

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

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

Study design	A two-arm parallel group randomised controlled pilot trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	03/12/2007
Completion date	28/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	10-20
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

Scotland
United Kingdom

Study participating centre

Psychological Medicine & Symptoms Research Group

Edinburgh
EH10 5HF
United Kingdom

Sponsor information

University of Edinburgh, Lothian Health Board, University Hospitals Division (UK)
Hospital/treatment centre

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
Scotland
United Kingdom

Phone	+44 (0)131 242 9262
Email	mbrown11@miscorp.ed.ac.uk
Website	http://www.ed.ac.uk/
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Charity

Cancer Research UK (ref: C5547/A7375)
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?
Results article	results	01/09/2009		Yes	No