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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01248624
Recruitment Status : Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Behavioral: Early Palliative Care Referral Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial
Study Start Date : December 2006
Actual Primary Completion Date : June 2011
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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. 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.

  4. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248624


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Camilla Zimmermann, MD, PhD Princess Margaret Cancer Centre, University Health Network
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01248624    
Other Study ID Numbers: 06-0525-CE
17257 and 20509 and 700862 ( Other Grant/Funding Number: Canadian Cancer Society )
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Keywords provided by University Health Network, Toronto:
Palliative Care
Quality of Life
Satisfaction with Care