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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Health Network, Toronto.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
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

November 22, 2010
July 8, 2011
December 2006
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01248624 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial of Early Palliative Care for Patients With Advanced Cancer
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
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.
  • 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.
    Intervention: Behavioral: Early Palliative Care Referral
  • Placebo Comparator: Conventional Cancer Care
    This control arm receives standard cancer care.
    Intervention: Behavioral: Early Palliative Care Referral
Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
450
June 2014
June 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01248624
06-0525-CE, 17257 and 20509
Yes
Dr. Camilla Zimmermann, Head, Palliative Care Program, University Health Network, Princess Margaret Hospital, University Health Network, Toronto
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
Principal Investigator: Camilla Zimmermann, MD, PhD Princess Margaret Hospital, University Health Network
University Health Network, Toronto
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP