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

This study has been completed.
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: November 10, 2016
Last verified: November 2016
  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
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

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 305
Study Start Date: January 2012
Study Completion Date: October 2016
Primary Completion Date: October 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 Centre, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  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

Locations
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
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 ( Other Grant/Funding Number: CIHR-MOP106473 )
Study First Received: January 4, 2012
Last Updated: November 10, 2016

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 22, 2017