STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial

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.

NCT Number	NCT07446660
Lead Sponsor	University Health Network, Toronto
Conditions	Oncology
Enrollment	652 participants
Start Date	2026-03-23
Primary Completion	2030-05 (estimated)
Study Completion	2030-07 (estimated)
Updated on ClinicalTrials.gov	2026-04-28