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

December 8, 2023 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: 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: Conventional Cancer Care
This control arm receives standard cancer care.
Behavioral: 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.

What is the study measuring?

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.
Time Frame: Three months after enrollment.
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).
Time Frame: Three months after enrollment.
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).
Time Frame: 3 months after enrollment.
Patient communication with healthcare providers is measured by the CARES (Medical Interaction Subscale).
3 months after enrollment.
Patient and caregiver satisfaction with care.
Time Frame: 3 months after enrollment.
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).
Time Frame: 3 months after enrollment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Camilla Zimmermann, MD, PhD, Princess Margaret Cancer Centre, University Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimated)

November 25, 2010

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-0525-CE
  • 17257 and 20509 and 700862 (Other Grant/Funding Number: Canadian Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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