STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial (NCT07446660)
Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Princess Margaret Cancer Centre — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
- Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) (BEHAVIORAL)
- Early Palliative Care (EPC) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Princess Margaret Cancer Centre — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 340-4800
Email: katayoun.khorramak@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.