STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
University Health Network, Toronto
652 participants
Mar 23, 2026
INTERVENTIONAL
Conditions
Summary
Palliative care aims to improve quality of life for people with advanced illness, and early palliative care (EPC) has been shown to benefit patients with late-stage cancer. However, specialist teams do not have the capacity to see all patients; on the other hand, many who would benefit are not referred. To address this, the investigators created STEP2, a system that combines online symptom screening with targeted palliative referrals. Eligible patients with advanced cancer are randomly assigned to routine EPC-where all receive a referral-or to STEP2, where referrals occur only if moderate-to-severe symptoms are reported. Patients complete questionnaires on quality of life, satisfaction, symptoms, depression, and goals of care at baseline, 16 weeks, and 24 weeks. The study will assess whether STEP2 is as good as receiving routine EPC by comparing the results of the questionnaires in each group.
Eligibility
Inclusion Criteria5
- Age ≥18 years
- Stage IV cancer (endocrine-resistant ER+ breast and castration-resistant prostate cancer; stage 3 included for lung or pancreatic cancer)
- Oncologist-estimated Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Oncologist-estimated prognosis of 6-36 months
- Willingness to complete virtual ESAS-r+ screening before each appointment
Exclusion Criteria3
- Insufficient English literacy to complete study questionnaires
- Severe cognitive deficit, as per treating oncologist
- Receiving specialized palliative care
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Moderate-to-severe symptoms on the Edmonton Symptom Assessment System-revised (ESAS-r+) will trigger an alert to the study team and the study triage nurse. The triage nurse will review symptom scores and contact the patient within 2 business days to provide telephone advice. During the call, the nurse will offer to arrange an in-person or virtual palliative care clinic (PCC) visit. Participants who agree to a PCC referral will then receive at least monthly in-person and/or virtual PCC follow-up based on patient needs and provider preference, in addition to their usual oncology care.
Structured palliative care visits at least once per month soon after randomization. Visits may be conducted in-person or virtually and is delivered alongside usual oncology care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07446660