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CALM Phase 2b Pilot (CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353546
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: CALM Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Cancer and Living Meaningfully (CALM): Phase 2b Pilot Randomized Psychotherapy Trial in Patients With Advanced Cancer
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CALM
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
No Intervention: Usual Care



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

Secondary Outcome Measures :
  1. Major Depression Structured Clinical Interview for DSM Disorders (SCID) [ Time Frame: 6-months ]
    DSM: Diagnostic and Statistical Manual of Mental Disorders (APA, 2000)

  2. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 6-months ]
  3. Death and Dying Distress Scale (DADDS) [ Time Frame: 6-months ]
  4. Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12) [ Time Frame: 6-months ]
  5. Modified Experiences in Close Relationships (ECR M-16) [ Time Frame: 6-months ]
  6. Rosenberg Self-esteem Scale (RSES) [ Time Frame: 6-months ]
  7. Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: 6-months ]
  8. Quality of Life at the End of Life-Cancer Scale (QUAL-EC) [ Time Frame: 6-months ]
  9. Posttraumatic Growth Inventory (PTGI) [ Time Frame: 6-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353546


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Gary Rodin University Health Network, Toronto
Principal Investigator: Sarah Hales University Health Network, Toronto
Principal Investigator: Chris Lo University Health Network, Toronto
Publications of Results:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02353546    
Other Study ID Numbers: UHN 09-0855-C
MOP 106473 ( Other Grant/Funding Number: CIHR )
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by University Health Network, Toronto:
affective symptoms
cancer
depression
palliative care
pilot trial
psychotherapy
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms