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

ISRCTN	ISRCTN40568538
DOI	https://doi.org/10.1186/ISRCTN40568538
Protocol serial number	v1.1 12/05/08
Sponsors	University of Edinburgh, NHS Lothian - University Hospitals Division (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 13/05/2008
Registration date: 30/05/2008
Last edited: 04/04/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-treating-depression-people-with-cancer-smart-oncology-2

Contact information

Prof Michael Sharpe
Scientific

School of Molecular and Clinical Medicine
The University of Edinburgh
Kennedy Tower
Royal Edinburgh Hospital
Morningside Park
Edinburgh
EH10 5HF
United Kingdom

Phone	+44 (0)131 537 6672
Email	michael.sharpe@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled two-arm parallel-group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	SMaRT (Symptom Management Research Trials)
Study objectives	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(s)	Scotland A research ethics committee, 31/03/2008, ref: 08/MRE00/23
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Treatment response, measured at 24 week outcome data collection, defined as a reduction of 50% or more in the patients baseline SCL-20D score
Key secondary outcome measure(s)	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
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Total final enrolment	500
Key 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
Key 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.
Date of first enrolment	15/05/2008
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

The University of Edinburgh

Edinburgh
EH10 5HF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/09/2014		Yes	No
Results article	results	01/12/2015		Yes	No
Protocol article	protocol	30/03/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			04/04/2022	No	Yes

Editorial Notes

04/04/2022: Plain English results and total final enrolment added.
20/07/2016: Publication references added.