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Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial

18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

- Age ≥ 18 years

- Dx of stage IV cancer (metastatic); refractory to hormonal therapy for breast or
prostate cancer; stage III or IV for lung cancer.

- ECOG performance status ≤ 2 (estimated by primary oncologist)

- Prognosis of >6 months to 2 years (estimated by primary oncologist)

Exclusion Criteria:

- Insufficient English literacy to complete questionnaires

- Inability of pass the cognitive screening test (SOMC - Short Orientation Memory
Concentration test score <20 or >10 errors)

Type of Study:


Study Design:

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

Outcome Measure:

Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.

Outcome Description:

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.

Outcome Time Frame:

Three months after enrollment.

Safety Issue:


Principal Investigator

Camilla Zimmermann, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, University Health Network


Canada: Health Canada

Study ID:




Start Date:

December 2006

Completion Date:

June 2014

Related Keywords:

  • Cancer
  • Palliative Care
  • Quality of Life
  • Satisfaction with Care