Overview

This trial is active, not recruiting.

Condition cancer
Treatment early palliative care referral
Sponsor University Health Network, Toronto
Collaborator Canadian Cancer Society Research Institute (CCSRI)
Start date December 2006
End date June 2011
Trial size 461 participants
Trial identifier NCT01248624, 06-0525-CE, 17257 and 20509

Summary

Patients with advanced cancer often have numerous physical and psychological symptoms, which can negatively affect their quality of life. A palliative care team of different health care professionals (including doctors, nurses, social workers and therapists) specializes in treating these symptoms and offers support for patients and their families. However, palliative care teams are currently involved only in the last two months of a patient's life or not at all.

The main purpose of this study is to determine whether, compared to conventional cancer care, early involvement by a specialized symptom control and palliative care team in patients with advanced cancer will be associated with: better quality of life, greater patient and caregiver satisfaction with care, better symptom control, improved communication with healthcare providers and improved caregiver quality of life.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.
early palliative care referral
The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.
(Placebo Comparator)
This control arm receives standard cancer care.
early palliative care referral
The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Primary Outcomes

Measure
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.
time frame: Three months after enrollment.

Secondary Outcomes

Measure
Symptom control (patient outcome).
time frame: Three months after enrollment.
Communication with healthcare providers (patient outcome).
time frame: 3 months after enrollment.
Patient and caregiver satisfaction with care.
time frame: 3 months after enrollment.
Caregiver quality of life (caregiver outcome).
time frame: 3 months after enrollment.

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial
Principal investigator Camilla Zimmermann, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.