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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University Health Network, Toronto
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01506492
First received: January 4, 2012
Last updated: December 29, 2015
Last verified: December 2015
  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 patients with various types of cancer, including metastatic 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:


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
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.
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 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 Center, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with various types of cancer, including metastatic disease.

  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
  • 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
  • No 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 Psychosocial Oncology and Palliative Care Department at Princess Margaret Cancer Centre at the time of study approach
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506492

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

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

Publications:
Hales S, Lo C, Rodin G. Managing Cancer And Living Meaningfully (CALM) Therapy (Chapter 62) In: Holland JC, Breitbart WS, Butow PN, Jacobsen PB, Loscalzo MJ, McCorkle R, editors. Psycho-Oncology. 3. New York: Oxford University Press; 2015. pp. 487-91.

Responsible Party: University Health Network, Toronto
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: December 29, 2015
Health Authority: Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on April 27, 2016