Artikel: Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer

Individuals with advanced cancer experience substantial distress in response to disease burden and

impending mortality. Managing Cancer And Living Meaningfully (CALM) is a novel, brief, manualized

psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in

patients with advanced cancer. We conducted a randomized controlled trial to compare CALM with

usual care (UC) in this population.

Methods

Patients with advanced cancer were recruited from outpatient oncology clinics at a comprehensive

cancer center into an unblinded randomized controlled trial. Permuted block randomization stratified

by Patient Health Questionnaire-9 depression score allocated participants to CALM plus UC or to UC

alone. Assessments of depressive symptoms (primary outcome), death-related distress, and other

secondary outcomes were conducted at baseline, 3 months (primary end point), and 6 months (trial

end point). Analyses were by intention to treat. Analysis of covariance was used to test for outcome

differences between groups at follow-up, controlling for baseline. Mixed-model results are reported.

Results

Participants (n = 305) were recruited between February 3, 2012, and March 4, 2016, and randomly

assigned to CALM (n = 151) or UC (n = 154). CALM participants reported less-severe depressive

symptoms than UC participants at 3 months (D = 1.09; P = .04; Cohen’s d = 0.23; 95% CI, 0.04 to

2.13) and at 6 months (D = 1.29; P = .02; d = 0.29; 95% CI, 0.24 to 2.35). Significant findings for

greater end-of-life preparation at 6 months also favored CALM versus UC. No adverse effects were

identified.

Conclusion

Findings suggest that CALM is an effective intervention that provides a systematic approach to

alleviating depressive symptoms in patients with advanced cancer and addresses the predictable

challenges these patients face.