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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75905964
Enrollment
200
Registered
2008-11-28
Start date
2008-12-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in patients with cancer Mental and Behavioural Disorders Reaction to severe stress and adjustment disorders

Interventions

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 in

Sponsors

University of Edinburgh (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026