Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof Michael Sharpe
ORCID ID
Contact details
School of Molecular and Clinical Medicine
The University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
Morningside Park
Edinburgh
EH10 5HF
United Kingdom
+44 (0)131 537 6672
michael.sharpe@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1.1 12/05/08
Study information
Scientific title
SMaRT oncology-2: a two arm parallel group randomised controlled trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder ('Depression Care for People with Cancer') to usual care, compared to usual care alone in cancer patients
Acronym
SMaRT (Symptom Management Research Trials)
Study hypothesis
1. 'Depression Care for People with Cancer' as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline 20-item depression score from the Symptoms Checklist (SCL-20D) at 24 weeks
2. 'Depression Care for People with Cancer' as a supplement to usual care will cost more than usual care alone but will be more cost effective in achieving improvements in patients depression and quality of life
Ethics approval
Scotland A research ethics committee, 31/03/2008, ref: 08/MRE00/23
Study design
Multicentre randomised controlled two-arm parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression in patients with cancer
Intervention
Patients will be randomised to receive:
1. Usual care, or
2. Usual care plus 'Depression Care for People with Cancer'
Usual care arm:
The usual care of depression from the patient's GP or oncologist (this is routine care and won't be influenced by the researchers)
Usual care plus 'Depression Care for People with Cancer' arm:
In addition to usual care as above a complex intervention for depression delivered by a specially trained cancer nurse under the supervision of a psychiatrist, a maximum of 10 treatment sessions delivered over 16 weeks followed by monthly monitoring of progress until 12 months. The intervention comprises education about depression and its treatments (including antidepressant medication, which would be prescribed by the GP if the patient wishes to take it, and behavioural activation) and problem solving treatment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Treatment response, measured at 24 week outcome data collection, defined as a reduction of 50% or more in the patients baseline SCL-20D score
Secondary outcome measures
1. Remission of major depressive disorder, defined as an SCL-20D score of less than 0.75 at each of 24, 36 and 48 weeks (higher than in primary care trials, to allow for cancer-related somatic symptoms)
2. Depression severity, defined for each patient as the average of their SCL-20D score at 24, 36 and 48 weeks
Overall trial start date
15/05/2008
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients must:
1. Have a diagnosis of cancer, with active disease within the last five years
2. Be aged 18 or over, either sex
3. Be attending a specialist oncology clinic
4. Have a predicted survival, estimated by their cancer specialist, of twelve months or more
5. Have symptoms that meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria for major depressive disorder (MDD), with symptoms of the current major depressive episode (MDE) present for four weeks or more using the inclusive approach to diagnosis
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
1. Patients are unable to provide informed consent to participate
2. The episode of depression is chronic (defined as a history of continuous depression for at least two years)
3. They are judged to require urgent psychiatric care
4. They are receiving active psychiatric or psychological treatment from specialist mental health services
5. They have cognitive impairment or communication difficulties (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention
6. They have known cerebral metastases
7. They are unable to attend regularly for treatment sessions
8. The intervention is judged to be inappropriate due to a medical condition which requires alternative treatment
9. The 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. Their participation in the trial is judged to be inappropriate on other clinical grounds
N.B. Patients receiving active cancer treatments will not be excluded unless they fulfil one or more of the exclusion criteria listed above.
Recruitment start date
15/05/2008
Recruitment end date
01/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Edinburgh
Edinburgh
EH10 5HF
United Kingdom
Sponsor information
Organisation
University of Edinburgh (UK)
Sponsor details
c/o Marise Bucukoglu
Associate Director (Governance & Sponsorship)
Edinburgh Clinical Trials Unit
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9262
marise.bucukoglu@ed.ac.uk
Sponsor type
University/education
Website
Organisation
NHS Lothian - University Hospitals Division (UK)
Sponsor details
Research & Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Organisation
University of Edinburgh
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19331675
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25175478
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26652589
Publication citations
-
Protocol
Walker J, Cassidy J, Sharpe M, , The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients., Trials, 2009, 10, 18, doi: 10.1186/1745-6215-10-18.
-
Results
Sharpe M, Walker J, Holm Hansen C, Martin P, Symeonides S, Gourley C, Wall L, Weller D, Murray G; SMaRT (Symptom Management Research Trials) Oncology-2 Team, Integrated collaborative care for comorbid major depression in patients with cancer (SMaRT Oncology-2): a multicentre randomised controlled effectiveness trial, Lancet, 2014, 384, 9948, 1099-1108, doi: 10.1016/S0140-6736(14)61231-9.
-
Results
Duarte A, Walker J, Walker S, Richardson G, Holm Hansen C, Martin P, Murray G, Sculpher M, Sharpe M, Cost-effectiveness of integrated collaborative care for comorbid major depression in patients with cancer, J Psychosom Res, 2015 , 79, 6, 465-470, doi: 10.1016/j.jpsychores.2015.10.012.