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

NCT01248624 | Active Not Recruiting DMC

• 2 other identifiers: 06-0525-CE17257 and 20509 and 700862
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Palliative Care; Quality of Life; Satisfaction with Care

Outcome Measures

Primary Outcomes (1)

• Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.

  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 Outcomes (4)

• Symptom control (patient outcome).

  Three months after enrollment.

• Communication with healthcare providers (patient outcome).

  3 months after enrollment.

• Patient and caregiver satisfaction with care.

  3 months after enrollment.

• Caregiver quality of life (caregiver outcome).

  3 months after enrollment.

Study Arms (2)

Early Palliative Care Referral

ACTIVE COMPARATOR

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

Conventional Cancer Care

PLACEBO COMPARATOR

This control arm receives standard cancer care.

Behavioral: Early Palliative Care Referral

Interventions

Early Palliative Care Referral BEHAVIORAL

The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Conventional Cancer Care; Early Palliative Care Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Insufficient English literacy to complete questionnaires
• Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score \<20 or \>10 errors)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (7)

• 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.

  PMID: 24559581 BACKGROUND

• 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.

  PMID: 27687308 BACKGROUND

• 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.

  PMID: 27091801 BACKGROUND

• 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.

  PMID: 35142091 DERIVED

• 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. 2023 Oct;13(e1):e74-e77. doi: 10.1136/bmjspcare-2021-002893. Epub 2021 Feb 22.

  PMID: 33619220 DERIVED

• 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.

  PMID: 33419858 DERIVED

• 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.

  PMID: 29130418 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Camilla Zimmermann, MD, PhD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 25, 2010
• Study Start: December 1, 2006
• Primary Completion: June 1, 2011
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CA (1)