Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial
Twenty-four cancer outpatient clinics at Princess Margaret Hospital, Toronto have been
randomly assigned so that patients attending them will receive either early palliative care
(referral to the palliative care team) or routine cancer care.
Patients are recruited from Gastrointestinal, Lung, Genitourinary, Gynecology and Breast
clinics and are eligible to participate if they have advanced cancer, and have a life
expectancy of six months to two years.
Patients and their caregivers who agree to participate are asked to complete questionnaires
at baseline and every month for 4 months. These questionnaires ask about their quality of
life, and satisfaction with their medical care. After they have completed the 4-month
questionnaires, some patients and their caregivers will be interviewed, so that they can
describe in their own words their quality of life, satisfaction with care, and views about
palliative care. These interviews will be audiotaped and analyzed to provide additional
information that cannot be obtained by questionnaires alone.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.
Together, the FACT-G (Functional Assessment of Cancer Therapy-General), QUAL-E (Quality of Life at the End of Life), and FACIT-Sp ('Meaning and Peace' and 'Faith' subscales) measure physical, social/family, emotional, functional and existential well-being.
Three months after enrollment.
No
Camilla Zimmermann, MD, PhD
Principal Investigator
Princess Margaret Hospital, University Health Network
Canada: Health Canada
06-0525-CE
NCT01248624
December 2006
June 2014
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