Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-03-27
2026-02-01
Brief Summary
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Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months.
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Detailed Description
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The investigators propose to test STEP2 in a single-arm pilot trial, enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years. Participants will complete the Edmonton Symptom Assessment System-revised (ESAS-r+) tool electronically before oncology appointments (as is usual care in Ontario, Canada); in addition, if patients report moderate to high symptom scores, they will receive nurse-led triage and targeted referral to specialized palliative care. Quality of life, symptom burden, depression, anxiety and satisfaction with care will be assessed at baseline, 2, 4, and 6 months using questionnaires.
The objectives of this study are 1) to assess the feasibility of the STEP2 intervention, including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person; and 2) to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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STEP2
Moderate-to-severe symptoms on the Edmonton Symptom Assessment System-revised (ESAS-r+) tool will trigger an email to the study team and the study triage nurse. The study triage nurse will review the scores via electronic medical record and call the patient within 2 business days to offer immediate advice by phone. During the phone call, the study triage nurse will offer to schedule a formal in-person or virtual palliative care clinic (PCC) visit. Participants agreeing to the PCC referral subsequently receive at least monthly in-person and/or virtual PCC follow-up visits until study end, based on patient needs and care provider preference.
Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden.
Interventions
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Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden.
Eligibility Criteria
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Inclusion Criteria
* stage IV cancer (stage III or IV for lung or pancreas cancers; hormone-refractory for prostate and ER-positive breast cancers)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* oncologist-estimated prognosis of 6-36 months
* willingness to complete routine online symptom screening at the Princess Margaret Cancer Centre
Exclusion Criteria
* oncologist-determined poor cognitive status
* already received or currently receiving specialized palliative care
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Camilla Zimmermann
Principal Investigator
Principal Investigators
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Camilla Zimmermann, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-5933
Identifier Type: -
Identifier Source: org_study_id
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