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CALM Phase 2b Pilot (CALM)

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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

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE June 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • Major Depression Structured Clinical Interview for DSM Disorders (SCID) [ Time Frame: 6-months ]
    DSM: Diagnostic and Statistical Manual of Mental Disorders (APA, 2000)
  • 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 Measures  ICMJE
 (submitted: January 28, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CALM Phase 2b Pilot
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: CALM
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: CALM
  • No Intervention: Usual Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353546
Other Study ID Numbers  ICMJE UHN 09-0855-C
MOP 106473 ( Other Grant/Funding Number: CIHR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Gary Rodin University Health Network, Toronto
Principal Investigator: Sarah Hales University Health Network, Toronto
Principal Investigator: Chris Lo University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP