Strong, V., Waters, R., Hibberd, C., Murray, G., Wall, L., Walker, J., . . . Sharpe, M. (2008). Management of depression for people with cancer (SMaRT oncology 1): a randomised trial. Lancet, 372, 40–48.

To determine the effectiveness of integrating a depression management program into the care of patients with cancer and major depressive disorder (MDD).

Patients were randomized into the treatment group or the usual care group. The treatment group received up to 10 individual one-to-one 45-minute sessions over a three-month period; some occurred via telephone or in the patients' homes, as needed. The intervention consisted of education about depression and its treatment, problem-solving and coping strategies, and collaboration with each patient’s oncologist and primary care provider. Two repeat sessions were offered to persons whose Patient Health Questionnaire-9 (PHQ-9) scores were increasing. No further intervention occurred after six months, but a progress-monitoring interview was conducted at 12 months.

• The sample was comprised of 200 patients.
• Mean patient age in each group was 56.6 years.
• The usual care group included 71 women and 28 men, and the intervention group included 70 women and 31 men.
• Patients had breast, colorectal, gynecologic, genitourinary, hematologic, lung, and mixed cancers.
• Patients were eligible based on the presence of MDD antidepressant therapy (any dose or therapeutic dose). Symptoms (depression, anxiety, pain, fatigue, and physical functioning) were also identified.

• Home visit or telephone visit, if patients were unable to attend the single site
• Regional cancer treatment center in Scotland, United Kingdom

Patients were undergoing the active treatment and transitional phases of care.

The study was a randomized trial with a control (usual care) group.

• Hospital Anxiety and Depression Scale (HADS)
• Structured Clinical Interview for DSM-IV (SCID-IV), to determine if patients met the criteria for MDD
• PHQ-9, to assess the severity of depression
• Hopkins Symptom Checklist (SCL-20) depression scale, to measure changes in depression
• A 10-item subscale of the Symptom Checklist-90 (SCL-90) questionnaire, to measure anxiety
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• EuroQol EQ-5D questionnaire, to measure quality of life for economic analysis

Measurements revealed no statistically significant differences in the two groups at baseline, including differences in the use of antidepressant medication. However, at three and six months, more patients in the intervention group than in the control group were using a therapeutic level of antidepressants. Depression scores on the SCL-20 decreased between baseline and three months in both groups, but the scores decreased more in the intervention group. More patients in the intervention group had a depression score that decreased by at least 50% from baseline to the three-month follow-up (p = 0.0008). In addition, several patients in the intervention group no longer met the criteria for MDD at three months and had reduced anxiety and fatigue. The study showed no significant changes in pain or physical functioning at three or six months. In addition, at six and 12 months, the study showed a significant improvement in quality of life for patients in the intervention group.

Supplementation of usual care with a nurse-delivered intervention for the management of depression reduced the symptoms of depression, anxiety, and fatigue more than usual care alone. There were no significant improvements in pain or physical functioning. The authors noted the close relationship of anxiety and fatigue to depression as a possible rationale for the cluster of improvements.

• The study had risk of bias due to no attentional control.
• Patient bias may have affected the outcome assessments:  the Hawthorne effect may have applied because patients knew that management of depression was taught.

A cost-effective, patient-acceptable, nurse-delivered intervention can support the management of depression, anxiety, and fatigue in patients with cancer and MDD. At 12 months, the evidence showed a sustained effect of the three-month intervention.