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| ID | Type | Description | Link |
|---|---|---|---|
| MOP 106473 | Other Grant/Funding Number | CIHR |
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| Name | Class |
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| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALM | Experimental | 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. |
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| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALM | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 6-months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Rodin | University Health Network, Toronto | Principal Investigator |
| Sarah Hales | University Health Network, Toronto | Principal Investigator |
| Chris Lo | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26787360 | Result | Lo C, Hales S, Chiu A, Panday T, Malfitano C, Jung J, Rydall A, Li M, Nissim R, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. BMJ Support Palliat Care. 2019 Jun;9(2):209-218. doi: 10.1136/bmjspcare-2015-000866. Epub 2016 Jan 19. |
| Label | URL |
|---|---|
| Publication in BMJ Supportive and Palliative Care | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000342 | Affective Symptoms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |