Clinical Trial: CALM Phase 2b Pilot

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary:
Sponsor: University Health Network, Toronto

Current Primary Outcome: Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Major Depression Structured Clinical Interview for DSM Disorders (SCID) [ Time Frame: 6-months ]
  • Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 6-months ]
  • Death and Dying Distress Scale (DADDS) [ Time Frame: 6-months ]
  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) [ Time Frame: 6-months ]
  • Modified Experiences in Close Relationships (ECR M-16) [ Time Frame: 6-months ]
  • Rosenberg Self-esteem Scale (RSES) [ Time Frame: 6-months ]
  • Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: 6-months ]
  • Quality of Life at the End of Life-Cancer Scale (QUAL-EC) [ Time Frame: 6-months ]
  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 6-months ]


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: January 28, 2015
Date Started: June 2011
Date Completion:
Last Updated: December 29, 2015
Last Verified: December 2015