STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial

Recruiting now · Not applicable

Conditions studied: Oncology

In brief

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.

Key facts

Study ID

NCT07446660

Run by

University Health Network, Toronto

People needed

652

Starts

2026-03-23

Expected to finish

2030-07-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Insufficient English literacy to complete study questionnaires
• Severe cognitive deficit, as per treating oncologist
• Receiving specialized palliative care

Where it is running

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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