Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Palliative Care Referral | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Early Palliative Care Referral
- description
- The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.
- interventionNames
- Behavioral: Early Palliative Care Referral
- type
- PLACEBO_COMPARATOR
- label
- Conventional Cancer Care
- description
- This control arm receives standard cancer care.
- interventionNames
- Behavioral: Early Palliative Care Referral
Primary outcomes (1)
- measure
- Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (7)
- BACKGROUNDZimmermann 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
- BACKGROUNDMcDonald 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
- BACKGROUNDZimmermann 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
- DERIVEDRodin 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
- DERIVEDMah 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
- DERIVEDMah 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