Pancreatic Cancer Research

Clinical trialNACompleted

CALM Phase 2b Pilot

Managing Cancer and Living Meaningfully (CALM): Phase 2b Pilot Randomized Psychotherapy Trial in Patients With Advanced Cancer

NCT02353546↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
NA
Status
Completed
Study type
Interventional
Start
June 2011
Expected end
August 2012
Enrollment
60 participants
Sites
1
Primary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Sponsor
Other
Results posted
No
Last update
7 August 2023

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Brief summary public domain (ClinicalTrials.gov)

Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis of major depression (SCID), death anxiety, attachment security and spiritual wellbeing. Multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.

Detailed description public domain (ClinicalTrials.gov)

Abstract Background Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT). Aims To test trial methodology and assess feasibility of a confirmatory RCT. Design A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting. Setting/participants 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre. Trial registration number NCT02353546. http://dx.doi.org/10.1136/bmjspcare-2015-000866

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.