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Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients (CALM)

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ClinicalTrials.gov Identifier: NCT01506492
Recruitment Status : Completed
First Posted : January 10, 2012
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 4, 2012
First Posted Date  ICMJE January 10, 2012
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-months ]
A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2012)
  • Structured Clinical Interview for DSM Disorders (SCID)-Research Version [ Time Frame: 6-months ]
    A semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria. Portions of the Mood Disorders and Optional Disorders modules will be administered: major depressive episode and minor depressive disorder.
  • Generalized Anxiety Disorders-7 (GAD-7) [ Time Frame: 6-months ]
    A widely used and validated 7-item self-report measure designed to screen and assess the severity of GAD symptoms.
  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) [ Time Frame: 6-months ]
    A 12-item self-report measure of spiritual well-being, assessing spiritual meaning and peace, and faith, that has been widely used in palliative care research.
  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 6-months ]
    A 21-item self-report scale that measures positive psychological changes after trauma. It has been used as a measure of psychological growth in cancer and as an outcome measure for intervention studies.
  • Quality of Life at the End of Life-Cancer Scale (QUAL-EC) [ Time Frame: 6-months ]
    A measure of quality of life in patient populations near the end of life.
  • Death and Dying Distress Scale (DADDS) [ Time Frame: 6-months ]
    A recently developed, 15-item measure assessing death anxiety in patients with advanced cancer.
  • Demoralization Scale (DS) [ Time Frame: 6-months ]
    A 24-item self-report measure that assesses one aspect of existential distress, which includes loss of meaning and purpose, disheartenment and helplessness.
  • Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M-16) [ Time Frame: 6-months ]
    A 16-item self-report measure of attachment security.
  • Couple Communication Scale (CCS) [ Time Frame: 6-months ]
    A measure for participants who are married, common-law, or in a long-term relationship. This measure is concerned with an individual's feelings, beliefs, and attitudes about the communication in his/her relationship.
  • Clinical Evaluation Questionnaire (CEQ) [ Time Frame: 6-months ]
    A 7-item measure evaluating the extent to which patients felt emotionally supported by the clinical services provided.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2012)
  • Structured Clinical Interview for DSM Disorders (SCID)-Research Version [ Time Frame: 6-months ]
    A semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria. Portions of the Mood Disorders and Optional Disorders modules will be administered: major depressive episode and minor depressive disorder.
  • Generalized Anxiety Disorders-7 (GAD-7) [ Time Frame: 6-months ]
    A widely used and validated 7-item self-report measure designed to screen and assess the severity of GAD symptoms.
  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) [ Time Frame: 6-months ]
    A 12-item self-report measure of spiritual well-being, assessing spiritual meaning and peace, and faith, that has been widely used in palliative care research.
  • Posttraumatic Growth Inventory (PTGI) [ Time Frame: 6-months ]
    A 21-item self-report scale that measures positive psychological changes after trauma. It has been used as a measure of psychological growth in cancer and as an outcome measure for intervention studies.
  • Quality of Life at the End of Life-Cancer Scale (QUAL-EC) [ Time Frame: 6-months ]
    A measure of quality of life in patient populations near the end of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients
Official Title  ICMJE Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer
Brief Summary The purpose of this study is to test the effectiveness of a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and promote psychological well-being in patients with various types of cancer, including metastatic disease.
Detailed Description

We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in patients with various types of cancer, including metastatic disease. We propose to conduct a two-arm randomized controlled trial (RCT) to test the effectiveness of CALM against usual care (UC) for the reduction of distress in patients with various types of cancer, including metastatic disease. Usual care at our center includes routine screening for depression and other distress in oncology outpatient clinics, communication of screening information to the medical treatment team, and referral as needed for non-standardized, and primarily instrumental, psychosocial care and psychiatric assessment and treatment.

The design will be an unblinded RCT consisting of two conditions (CALM and UC), with a baseline assessment and follow-ups at three and six months. The trial will take place in Princess Margaret Cancer Centre, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with various types of cancer, including metastatic disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: 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.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Usual care includes routine screening for depression and other distress in oncology outpatient clinics, communication of screening information to the medical treatment team, and referral as needed.
  • 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
Publications *

*   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: November 10, 2016)
305
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2012)
604
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years of age
  • Fluency in English
  • Confirmed diagnosis of stage III or IV lung cancer; any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary/peri-ampullary cancer, or other stage IV (metastatic) gastrointestinal cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancers; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (all with expected survival of 12-18 months)

Exclusion Criteria:

  • Major communication difficulties (including language barriers)
  • Inability to commit to the required 3-6 psychotherapy sessions
  • Cognitive impairment indicated in the medical record, or by the attending oncologist, or as indicated by a score < 20 on the Short Orientation-Memory-Concentration test, unless deemed suitable at the recruiter's discretion
  • Actively seeing a psychiatrist or psychologist in the Department of Supportive Care (formerly the Department of Psychosocial Oncology and Palliative Care) at Princess Margaret Cancer Centre at the time of study approach
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT01506492
Other Study ID Numbers  ICMJE UHN REB 09-0855-C
CIHR ( Other Grant/Funding Number: CIHR-MOP106473 )
Has Data Monitoring Committee Yes
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, MD University Health Network, Toronto
Principal Investigator: Sarah Hales, MD, PhD University Health Network, Toronto
Principal Investigator: Chris Lo, PhD 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