Rodriguez Vega, B., Palao, A., Torres, G., Hospital, A., Benito, G., Perez, E., . . . Bayon, C. (2011). Combined therapy versus usual care for the treatment of depression in oncologic patients: A randomized controlled trial. Psycho-Oncology, 20(9), 943–952.

To compare the effects—on quality of life and symptoms of depression—of an intervention consisting of a psychotherapeutic intervention, narrative therapy, plus escitalopram to the effects of usual care plus escitalopram

The initial sample was composed of 1,026 patients, between March 2006 and June 2008, with a diagnosis of breast, lung, or colorectal nonmetastatic cancer, three months after cancer diagnosis and no later than two years after diagnosis. Investigators used the Hospital and Anxiety Depression Scale (HADS) to screen participants for depression. A total of 150 had depressive disorder according to DSM-IV-TR criteria. The study contained 72 participants, 33 in usual care and 39 in combined care. Escitalopram was administered on a fixed-flexible schedule in both groups, beginning with 10 mg per day and adjusted up to 20 mg per day by week 8. A minimum of six months treatment was established for both groups. The narrative intervention was carried out individually during 12 weekly sessions, each 45 minutes long, and was guided by a treatment manual. Of the sessions, 10% were videotaped to help ensure adherence. Usual care consisted of oncologist-adminstered antidepressant. The oncologist followed a protocol and reported side effects of the medication. The follow-up of patients in the usual-care group was similar to that of patients in the treatment group. Investigators assessed depression-related outcome at weeks 12 and 24.

• The sample was composed of 72 participants. At the 12-week assessment, the sample contained 68 participants. At the 24-week assessment, the sample contained 56 participants.
• Mean patient age was 54.6 years (SD = 10.4 years). The age range was 35–75 years.
• The sample contained 19.4% males and 80.6% females.
• Participants had lung, breast, or colorectal nonmetastatic cancer and major depressive disorder, single-episode or major recurrent depressive disorder, or adjustment disorder with depressed mood, or adjustment disorder with mixed anxiety and depressed mood.
• Participants had a life expectancy longer than one year and a Karnofsky Performance Status Score of 70 or higher. Participants were receiving ambulatory care and had depressive disorder according to DSM-IV-TR criteria.
   

• Multisite
• Outpatient
• Madrid, Spain

• Phases of care: multiple
• Clinical applications: late effects and survivorship

Two-center randomized controlled trial

• European Organization for Research and Treatment Cancer Core Quality of Life C30 (EORTC QLQ-C30), a self-rating scale that measures quality of life. Thirty items evaluate five functional domains and three scales of symptoms. Five items assess common physical symptoms of cancer. Other items assess global health, global quality of life, and the perceived financial impact of disease and treatment. Scores are 0–100. The EORTC QLQ-C30 has been validated for use by Spanish patients with cancer.    
• Hospital anxiety and depression scale (HADS). Investigators used this scale at baseline, for screening, and at 12 and 24 weeks. HADS is a 14-item self-rating scale that measures anxiety and depression and is designed specifically for patients with physical illness. A score of 11 or more indicates probable psychological morbidity; a score of 8–10 indicates possible psychological morbidity. The scale has been validated for use by Spanish patients.

Demographic variables did not differ significantly between the two groups. Gender and age were unbalanced because of cancer types. At 12 and 24 weeks, the combined-therapy group showed significantly greater improvement in all the dimensions of function (p < 0.01), pain scale (p = 0.02), global health (p = 0.02), and global quality of life (p = 0.007). Between groups there were no statistically significant differences in symptoms of depression. From week 12 to 24, study retention was higher in the combined-treatment group (p = 0.01).

Using combined therapy for major depression in patients with cancer results in significant improvements in quality of life but does not result in a significant reduction in symptoms of depression. Narrative therapy is an integrative intervention designed to address components of critical importance in patients with depression. The therapy may have a positive impact on patient’s fears and worries about medication interactions and side effects.

• The study had a small sample size, with fewer than 100 participants.
• Types of cancer were not evenly distributed between groups.
• The study used interim analysis to estimate statistical power and sample size.
• A different specialist administered the drug.
   

The interventions proved to be acceptable to patients. The intervention shows good potential for dissemination, is relatively easy to implement, and improved compliance. The intervention may be a low-cost means of improving the quality of life of patients with cancer.