Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner.
The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics.
Condition or disease | Intervention/treatment | Phase |
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Cancer | Behavioral: Symptom screening with Targeted Early Palliative Care (STEP) | Not Applicable |
Randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable.
Consenting patients from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics will be assigned randomly either to receive STEP or to follow usual symptom screening. All patients will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The investigators will measure the impact of STEP on these outcomes, compared to screening alone.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial |
Actual Study Start Date : | August 8, 2019 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2025 |
Arm | Intervention/treatment |
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Experimental: Symptom screening with Targeted Early Palliative Care (STEP)
The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
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Behavioral: Symptom screening with Targeted Early Palliative Care (STEP)
The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
Other Name: STEP
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No Intervention: Standard Oncology Care
The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 2V7 | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada, M5G 2C1 |
Principal Investigator: | Camilla Zimmermann, MD, PhD | University Health Network, Toronto |
Tracking Information | |||||
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First Submitted Date ICMJE | June 13, 2019 | ||||
First Posted Date ICMJE | June 17, 2019 | ||||
Last Update Posted Date | April 19, 2021 | ||||
Actual Study Start Date ICMJE | August 8, 2019 | ||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. [ Time Frame: 6 months after enrollment. ] The FACT-G7 (Functional Assessment of Cancer Therapy-General 7 item) is a 7-item measure for quality of life that has been validated in patients with advanced cancer. Total score ranges from 0-28, higher scores indicate better quality of life.
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Original Primary Outcome Measures ICMJE |
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. [ Time Frame: 6 months after enrollment. ] The FACT-G7 (Functional Assessment of Cancer Therapy-General 7 item) is a 7-item measure for quality of life that has been validated in patients with advanced cancer.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer | ||||
Official Title ICMJE | Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial | ||||
Brief Summary |
Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner. The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics. |
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Detailed Description |
Randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable. Consenting patients from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics will be assigned randomly either to receive STEP or to follow usual symptom screening. All patients will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The investigators will measure the impact of STEP on these outcomes, compared to screening alone. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Cancer | ||||
Intervention ICMJE | Behavioral: Symptom screening with Targeted Early Palliative Care (STEP)
The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
Other Name: STEP
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
69 | ||||
Original Estimated Enrollment ICMJE |
522 | ||||
Estimated Study Completion Date ICMJE | December 2025 | ||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03987906 | ||||
Other Study ID Numbers ICMJE | 19-5007 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University Health Network, Toronto | ||||
Study Sponsor ICMJE | University Health Network, Toronto | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University Health Network, Toronto | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |