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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Health Questionnaire-9 (PHQ-9)
A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.
Gary Rodin, MD, FRCPC
University Health Network, Toronto
Canada: Canadian Institutes of Health Research
UHN REB 09-0855-C