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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Cancer Society
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01248624
First received: November 22, 2010
Last updated: July 8, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Cancer
 Behavioral: Early Palliative Care Referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp. [ Time Frame: Three months after enrollment. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Symptom control (patient outcome). [ Time Frame: Three months after enrollment. ] [ Designated as safety issue: No ]
    The patient outcome of 'symptom control' is measured by the ESAS (Edmonton Symptom Assessment System).

  • Communication with healthcare providers (patient outcome). [ Time Frame: 3 months after enrollment. ] [ Designated as safety issue: No ]
    Patient communication with healthcare providers is measured by the CARES (Medical Interaction Subscale).

  • Patient and caregiver satisfaction with care. [ Time Frame: 3 months after enrollment. ] [ Designated as safety issue: No ]
    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.

  • Caregiver quality of life (caregiver outcome). [ Time Frame: 3 months after enrollment. ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 450
Study Start Date: December 2006
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248624

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Society
Investigators
Principal Investigator: Camilla Zimmermann, MD, PhD Princess Margaret Hospital, University Health Network
  More Information

No publications provided

Responsible Party: Dr. Camilla Zimmermann, Head, Palliative Care Program, University Health Network, Princess Margaret Hospital, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01248624     History of Changes
Other Study ID Numbers: 06-0525-CE, 17257 and 20509
Study First Received: November 22, 2010
Last Updated: July 8, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Palliative Care
Quality of Life
Satisfaction with Care

ClinicalTrials.gov processed this record on June 18, 2013