Elsevier

The Lancet Oncology

Volume 15, Issue 10, September 2014, Pages 1168-1176
The Lancet Oncology

Articles
Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer

https://doi.org/10.1016/S1470-2045(14)70343-2Get rights and content

Summary

Background

The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care.

Methods

Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0–4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964.

Findings

142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference −0·38 (95% CI −0·58 to −0·18); standardised mean difference −0·62 (95% CI −0·94 to −0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group.

Interpretation

Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy.

Funding

Cancer Research UK and Chief Scientist Office of the Scottish Government.

Introduction

Survival has improved substantially for many cancers in recent decades, but for some, such as lung cancer, the outcome remains poor.1 Lung cancer accounts for 18% of cancer deaths worldwide and its incidence continues to rise.2, 3 Only 13% of patients survive for 5 years after a lung cancer diagnosis.4

Patients with lung cancer experience an especially high rate of major depression,5 which has a large negative effect on their symptoms, functioning, and quality of life.6, 7, 8 This negative effect of depression is particularly important for patients with poor prognosis cancers because it blights the often short period that they have left to live.

The management of major depression in patients with poor prognosis cancers presents special challenges; treatment needs to be both rapidly effective and deliverable in the context of progressive physical deterioration. Clinicians presently have little evidence to help them address this challenge—a situation that might partly explain the finding that depression is often treated inadequately.5, 9 We are aware of only a small amount of evidence in patients with major depression and cancer of any type, and no trials of treatment for major depression in patients with lung cancer.10, 11 Although effective treatments are available for people diagnosed with depression in the general population, we cannot assume that these will have the same benefits and harms in people whose depression is comorbid with lung cancer.

We have previously developed a manualised, multicomponent team-delivered treatment programme based on the collaborative care model, which integrates depression management into cancer care.12, 13 This treatment is effective for major depression in patients with good prognosis cancers.14, 15 We adapted it to meet the needs of patients with lung cancer with the aims of achieving a rapid treatment response and enabling the patient to continue to receive treatment for depression despite their physical deterioration.

In this report, we describe an efficacy (proof-of-concept) randomised controlled trial comparing this integrated treatment programme—depression care for people with lung cancer—with usual care. We postulated that the depression care for people with lung cancer programme would reduce depression severity, averaged for each patient over the time they were able to take part in the trial (up to 32 weeks from randomisation), more than usual care.

Section snippets

Study design and participants

We did a parallel, two-group multicentre randomised controlled trial in three cancer centres in Scotland, UK (Glasgow, Edinburgh, and Dundee) and their associated clinics. The trial protocol, including an outline of the statistical analysis plan, has been published.16

We enrolled adults (≥18 years of age) with primary lung cancer, with a predicted survival of at least 3 months (estimated by cancer specialists), and major depression (Diagnostic and Statistical Manual of Mental Disorders, fourth

Results

Between Jan 5, 2009, and Sept 9, 2011, 490 referrals were made to the trial team by the screening service (appendix p 16). 142 patients were eligible for and agreeable to participation; 68 were allocated to depression care for people with lung cancer and 74 to usual care (figure 1). More than half of the participants were women, the majority had non-small-cell lung cancer, and most were retired or unemployed (table 1). The median time since diagnosis of lung cancer was 7·1 months (IQR

Discussion

In this trial, the depression care for people with lung cancer intervention was better than usual care in reducing depression severity and in improving anxiety, quality of life, and role functioning in patients with major depression and lung cancer. Participants who received depression care for people with lung cancer also perceived their depression care to be of higher quality and were more likely to rate their depression as improved; most of those interviewed described it as helpful and said

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