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

This study is currently recruiting participants.
Verified February 2012 by University Health Network, Toronto
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01506492
First received: January 4, 2012
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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 cancer patients with advanced disease.


Condition Intervention Phase
Depression
 Behavioral: CALM
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.


Secondary Outcome Measures:
  • Structured Clinical Interview for DSM Disorders (SCID)-Research Version [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A measure of quality of life in patient populations near the end of life.

  • Death and Dying Distress Scale (DADDS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    A recently developed, 15-item measure assessing death anxiety in patients with advanced cancer.

  • Demoralization Scale (DS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A 16-item self-report measure of attachment security.

  • Couple Communication Scale (CCS) [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A 7-item measure evaluating the extent to which patients felt emotionally supported by the clinical services provided.


Estimated Enrollment: 604
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Experimental: CALM 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.

Detailed Description:

We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in cancer patients with advanced 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 metastatic cancer. 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 Hospital, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with metastatic cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Fluency in English
  • No cognitive impairment indicated in the medical record or by the attending oncologist
  • Confirmed diagnosis of "wet" stage IIIB (those not treated with curative intent) or IV lung cancer; any stage of pancreatic 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
  • A score <20 on the Short Orientation-Memory-Concentration (SOMC) test, indicating cognitive impairment unless deemed suitable at recruiter's discretion
  • Actively seeing a psychiatrist in the Psychosocial Oncology and Palliative Care Department at Princess Margaret Hospital at the time of study approach
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506492

Contacts
Contact: Aubrey Chiu (416) 340-4800 ext 2708 aubrey.chiu@uhnresearch.ca
Contact: Tania Panday (416) 340-4828 tpanday@uhnresearch.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Aubrey Chiu     (416) 340-4800 ext 2708     aubrey.chiu@uhnresearch.ca    
Contact: Tania Panday     (416) 340-4828     tpanday@uhnresearch.ca    
Principal Investigator: Gary Rodin, MD, FRCPC            
Principal Investigator: Sarah Hales, MD, FRCPC            
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Gary Rodin, MD, FRCPC University Health Network, Toronto
Principal Investigator: Sarah Hales, MD, FRCPC University Health Network, Toronto
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01506492     History of Changes
Other Study ID Numbers: UHN REB 09-0855-C, CIHR
Study First Received: January 4, 2012
Last Updated: February 2, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University Health Network, Toronto:
Randomized controlled trial
Depression
Cancer
Psychotherapy
Quality of life

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013