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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2027-12-31

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.

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Early Palliative Care Referral

Intervention Type BEHAVIORAL

The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Conventional Cancer Care

This control arm receives standard cancer care.

Group Type PLACEBO_COMPARATOR

Early Palliative Care Referral

Intervention Type BEHAVIORAL

The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Interventions

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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.

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No