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
Protocol serial number v1.0 25.09.08
Sponsor University of Edinburgh (UK)
Funder Cancer Research UK (CRUK) (UK)
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

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

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

Study information

Primary study designInterventional
Study designTwo-arm parallel-group randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleSMaRT 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 acronymSMaRT (Symptom Management Research Trials)
Study objectivesSupplementing 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) studiedDepression in patients with cancer
InterventionPatients 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 typeOther
Primary outcome measure(s)

Average depression severity, assessed using Symptom Checklist (SCL)-20D scores, collected every four weeks over 32 weeks.

Key secondary outcome measure(s)

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

Completion date01/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration200
Total final enrolment142
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2008
Date of final enrolment01/07/2011

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

School of Molecular and Clinical Medicine
Edinburgh
EH10 5HF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2014 Yes No
Protocol article protocol 30/09/2009 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 26/10/2022 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

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

BMC - Part of Springer Nature Springer Nature