CALM Phase 2b Pilot

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: CALM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Fluent in English Confirmed diagnosis of Stage IIIB or IV lung cancer, Stage III or IV ovarian cancer, Stage IV endocrine, breast, gastrointestinal, genitourinary or gynecologic cancer, or pancreatic cancer at any stage Exclusion Criteria: Short Orientation-Memory-Concentration Test (score of <20) Individuals receiving in-hospital psychiatric or psychological treatment at the time of recruitment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM<br>Patients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center. | Behavioral: CALM<br> <br> |
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Depression Structured Clinical Interview for DSM Disorders (SCID) | DSM: Diagnostic and Statistical Manual of Mental Disorders (APA, 2000) | 6-months | 
| Generalized Anxiety Disorder-7 (GAD-7) |  | 6-months | 
| Death and Dying Distress Scale (DADDS) |  | 6-months | 
| Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) |  | 6-months | 
| Modified Experiences in Close Relationships (ECR M-16) |  | 6-months | 
| Rosenberg Self-esteem Scale (RSES) |  | 6-months | 
| Acceptance and Action Questionnaire-II (AAQ-II) |  | 6-months | 
| Quality of Life at the End of Life-Cancer Scale (QUAL-EC) |  | 6-months | 
| Posttraumatic Growth Inventory (PTGI) |  | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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affective symptoms, cancer, depression, palliative care, pilot trial, psychotherapy