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Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer

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.

Inclusion Criteria:

- ≥18 years of age

- Fluency in English

- No cognitive impairment indicated in the medical record or by the attending

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Health Questionnaire-9 (PHQ-9)

Outcome Description:

A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Gary Rodin, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Canadian Institutes of Health Research

Study ID:

UHN REB 09-0855-C



Start Date:

January 2012

Completion Date:

December 2016

Related Keywords:

  • Depression
  • Randomized controlled trial
  • Depression
  • Cancer
  • Psychotherapy
  • Quality of life
  • Depression
  • Depressive Disorder