Clinical trial NCT01248624: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Palliative Care
Quality of Life
Satisfaction with Care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2010-11-25
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G, QUAL-E and FACIT-Sp.
timeFrame: Three months after enrollment.
Secondary outcomes:
measure: Symptom control (patient outcome).
timeFrame: Three months after enrollment.
measure: Communication with healthcare providers (patient outcome).
timeFrame: 3 months after enrollment.
measure: Patient and caregiver satisfaction with care.
timeFrame: 3 months after enrollment.
measure: Caregiver quality of life (caregiver outcome).
timeFrame: 3 months after enrollment.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre, University Health Network
name: Camilla Zimmermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.