Rodin G, et al. - Considering the substantial distress experienced by individuals with advanced cancer due to disease burden and impending mortality, researchers compared the impact of Managing Cancer And Living Meaningfully (CALM) (a psychotherapeutic intervention) vs usual care (UC) for these patients via a randomized controlled trial. Results suggest CALM is an efficacious intervention providing a systematic approach to improving depressive symptoms in these patients. This intervention also addresses the predictable challenges these patients face.

Methods

• From outpatient oncology clinics at a comprehensive cancer center, researchers recruited patients with advanced cancer into an unblinded randomized controlled trial.
• Using permuted block randomization stratified by Patient Health Questionnaire-9 depression score, they assigned participants to CALM plus UC or to UC alone.
• At baseline, 3 months (primary end point), and 6 months (trial end point), they assessed depressive symptoms as the primary outcome, and death-related distress and other secondary outcomes.
• They performed analyses via intention to treat.
• Using analysis of covariance, they determined outcome differences between groups at follow-up, controlling for baseline.
• They reported mixed-model results.

Results

• From February 3, 2012 to March 4, 2016, researchers recruited and randomly assigned participants (n=305) to CALM (n=151) or UC (n=154).
• Less severe depressive symptoms were reported in CALM participants vs UC participants at 3 months, (Δ=1.09; P=.04; Cohen’s d=0.23; 95% CI, 0.04 to 2.13) and at 6 months (Δ=1.29; P=.02; d = 0.29; 95% CI, 0.24 to 2.35).
• Compared to UC, CALM had more favorable results in terms of significantly greater end-of-life preparation at 6 months.
• They identified no adverse effects.