SMaRT Oncology-3: a two-arm parallel group randomised controlled trial to determine the efficacy of adding a complex intervention for major depressive disorder ("Depression Care for People with Lung Cancer") to usual care, compared to usual care alone in patients with lung cancer

ISRCTN	ISRCTN75905964
DOI	https://doi.org/10.1186/ISRCTN75905964
Secondary identifying numbers	v1.0 25.09.08

Submission date: 18/11/2008
Registration date: 28/11/2008
Last edited: 26/10/2022

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-lung-cancer-smart-oncology-3

Study website

Contact information

Prof Michael Sharpe
Scientific

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

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

Study information

Study design	Two-arm parallel-group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	SMaRT Oncology-3: a two-arm parallel group randomised controlled trial to determine the efficacy of adding a complex intervention for major depressive disorder ("Depression Care for People with Lung Cancer") to usual care, compared to usual care alone in patients with lung cancer
Study acronym	SMaRT (Symptom Management Research Trials)
Study objectives	Supplementing usual care with "Depression Care for People with Lung Cancer" will improve the following over eight months (32 weeks): 1. Depressive symptoms 2. Other symptoms (pain, fatigue, anxiety) 3. Functioning 4. Quality of life 5. Satisfaction with depression care The pilot study for this trial can be found on the ISRCTN Register under ISRCTN16242820. In addition to this, a related trial SMaRT Oncology-2 is can also be found on the ISRCTN Register under ISRCTN40568538.
Ethics approval(s)	Scotland A Research Ethics Committee on 23/10/2008 (ref: 08/MRE00/95)
Health condition(s) or problem(s) studied	Depression in patients with cancer
Intervention	Patients will be randomised to receive 'usual care' or 'usual care' plus "Depression Care for People with Lung Cancer". "Depression Care for People with Lung Cancer" is a complex intervention which includes education on depression and its treatments, and a problem solving treatment. It is delivered by specially trained cancer nurses supervised by psychiatrists. A maximum of 10 sessions over 16 weeks will be given, followed by monthly follow-up telephone conversations for a further 4 months. Sessions last 30 minutes to 1 hour. Details of Joint Sponsor: NHS Lothian - University Hospitals Division (UK) Research and Development Office Royal Infirmary of Edinburgh 51 Little France Crescent Edinburgh EH16 4SA United Kingdom
Intervention type	Other
Primary outcome measure	Average depression severity, assessed using Symptom Checklist (SCL)-20D scores, collected every four weeks over 32 weeks.
Secondary outcome measures	The following will be assessed every four weeks over 32 weeks: 1. Severity of anxiety symptoms, measured by the Symptom Checklist (SCL)-10A 2. Severity of pain and fatigue, measured by the relevant symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) 3. Physical, social and role functioning, and overall health and quality of life measured by the relevant scales of the EORTC QLQ-C30 4. Patient's satisfaction with depression care, measured by a 5-point Likert scale item developed specifically for the trial
Overall study start date	01/12/2008
Completion date	01/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Total final enrolment	142
Key inclusion criteria	1. Both males and females, aged 18 or over 2. Have a diagnosis of lung cancer 3. Have a predicted survival, estimated by their cancer specialist, of three months or more 4. Have symptoms which meet the 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. 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. Judged to require urgent psychiatric care 4. Receiving active psychiatric or psychological treatment from specialist mental health services 5. Cognitive impairment or communication difficulties (including inability to adequately understand verbal explanations or written information in English) which are incompatible with the intervention 6. Known cerebral metastases 7. Unable to participate regularly in 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. 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	01/12/2008
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

School of Molecular and Clinical Medicine

Edinburgh
EH10 5HF
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

c/o Marise Bucukoglu
Edinburgh Clinical Trials Unit
Western General Hospital
Edinburgh
EH4 2XR
Scotland
United Kingdom

Email	marise.bucukoglu@ed.ac.uk
Website	http://www.ed.ac.uk/
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
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	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	30/09/2009		Yes	No
Results article	results	01/09/2014		Yes	No
Plain English results			26/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.