Actively Recruiting
STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
Led by University Health Network, Toronto · Updated on 2026-04-28
652
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stage IV cancer (including endocrine-resistant ER+ breast and castration-resistant prostate cancer); stage 3 for lung or pancreatic cancer
- Oncologist-estimated ECOG performance status of 0 to 2
- Oncologist-estimated prognosis of 6 to 36 months
- Willingness to complete virtual symptom screening before each appointment
You will not qualify if you...
- Insufficient English literacy to complete study questionnaires
- Severe cognitive deficit as determined by the treating oncologist
- Currently receiving specialized palliative care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
Research Team
K
Kathy Khorramak, BSc
CONTACT
S
Samantha Lo, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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