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

• ClinicalTrials.gov Identifier: NCT01248624
• Recruitment Status: Unknown
• First Posted: November 25, 2010
• Last Update Posted: April 23, 2021
• Sponsor: University Health Network, Toronto
• Collaborator: Canadian Cancer Society (CCS)
• Information provided by (Responsible Party): University Health Network, Toronto

Tracking Information

• First Submitted Date: November 22, 2010
• First Posted Date: November 25, 2010
• Last Update Posted Date: April 23, 2021
• Study Start Date: December 2006
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 24, 2010)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 24, 2010)

• 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).
• 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).
• 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.
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Controlled Trial of Early Palliative Care for Patients With Advanced Cancer
• Official Title: Early Specialized Palliative Care Team Intervention for Patients With Metastatic Cancer: A Cluster Randomized Trial

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Cancer

Intervention

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.

Study Arms

• 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

Publications *

• 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.
• McDonald J, Swami N, Hannon B, Lo C, Pope A, Oza A, Leighl N, Krzyzanowska MK, Rodin G, Le LW, Zimmermann C. Impact of early palliative care on caregivers of patients with advanced cancer: cluster randomised trial. Ann Oncol. 2017 Jan 1;28(1):163-168. doi: 10.1093/annonc/mdw438.
• Zimmermann C, Swami N, Krzyzanowska M, Leighl N, Rydall A, Rodin G, Tannock I, Hannon B. Perceptions of palliative care among patients with advanced cancer and their caregivers. CMAJ. 2016 Jul 12;188(10):E217-E227. doi: 10.1503/cmaj.151171. Epub 2016 Apr 18.
• Rodin R, Swami N, Pope A, Hui D, Hannon B, Le LW, Zimmermann C. Impact of early palliative care according to baseline symptom severity: Secondary analysis of a cluster-randomized controlled trial in patients with advanced cancer. Cancer Med. 2022 Apr;11(8):1869-1878. doi: 10.1002/cam4.4565. Epub 2022 Feb 9.
• Mah K, Chow B, Swami N, Pope A, Rydall A, Earle C, Krzyzanowska M, Le L, Hales S, Rodin G, Hannon B, Zimmermann C. Early palliative care and quality of dying and death in patients with advanced cancer. BMJ Support Palliat Care. 2021 Feb 22:bmjspcare-2021-002893. doi: 10.1136/bmjspcare-2021-002893. Online ahead of print.
• Mah K, Swami N, O'Connor B, Hannon B, Rodin G, Zimmermann C. Early palliative intervention: effects on patient care satisfaction in advanced cancer. BMJ Support Palliat Care. 2022 Jun;12(2):218-225. doi: 10.1136/bmjspcare-2020-002710. Epub 2021 Jan 8.
• McDonald J, Swami N, Pope A, Hales S, Nissim R, Rodin G, Hannon B, Zimmermann C. Caregiver quality of life in advanced cancer: Qualitative results from a trial of early palliative care. Palliat Med. 2018 Jan;32(1):69-78. doi: 10.1177/0269216317739806. Epub 2017 Nov 13.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: May 27, 2015): 461
• Original Estimated Enrollment (submitted: November 24, 2010): 450
• Estimated Study Completion Date: December 2021
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01248624
• Other Study ID Numbers: 06-0525-CE; 17257 and 20509 and 700862 ( Other Grant/Funding Number: Canadian Cancer Society )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Health Network, Toronto
• Original Responsible Party: Dr. Camilla Zimmermann, Head, Palliative Care Program, University Health Network, Princess Margaret Hospital, University Health Network, Toronto
• Current Study Sponsor: University Health Network, Toronto
• Original Study Sponsor: Same as current
• Collaborators: Canadian Cancer Society (CCS)

Investigators

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

• PRS Account: University Health Network, Toronto
• Verification Date: April 2021