Randomized Controlled Trial of Early Palliative Care for Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Early Palliative Care Referral


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Palliative Care Referral<br>The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital. | Behavioral: Early Palliative Care Referral<br>* The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.<br>|
| Placebo Comparator: Conventional Cancer Care<br>This control arm receives standard cancer care. | Behavioral: Early Palliative Care Referral<br>* The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom control (patient outcome). | The patient outcome of 'symptom control' is measured by the ESAS (Edmonton Symptom Assessment System). | Three months after enrollment. | 
| Communication with healthcare providers (patient outcome). | Patient communication with healthcare providers is measured by the CARES (Medical Interaction Subscale). | 3 months after enrollment. | 
| Patient and caregiver satisfaction with care. | The outcome of 'satisfaction with care' is measured by the FAMCARE (Family Satisfaction with Cancer Scale) for primary caregivers. Patients complete a modified version of the FAMCARE scale. | 3 months after enrollment. | 
| Caregiver quality of life (caregiver outcome). | Caregiver quality of life is measured by Caregiver Quality of Life Index-Cancer (CQOL-C) and the SF-36 (Caregiver Health and Functioning Medical Outcomes Study Short-form). | 3 months after enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Quality of Life, Satisfaction with Care