STEP2 versus routine early palliative care for people with advanced cancer
Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
NA · University Health Network, Toronto · NCT07446660
This tests whether STEP2—online symptom screening with targeted palliative referrals—works as well as giving all eligible patients routine early palliative care for people with advanced cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 652 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07446660 on ClinicalTrials.gov |
What this trial studies
This randomized noninferiority trial enrolls outpatients with advanced cancer and a prognosis of 6–36 months and assigns them to either routine early palliative care referrals for all or to STEP2, which uses regular online symptom screening (ESAS-r+) and refers only patients with moderate-to-severe symptoms. STEP2 combines virtual and in-person palliative care options and relies on patients completing symptom screening before oncology visits. Patients complete questionnaires on quality of life, satisfaction, symptoms, depression, and goals of care at baseline, 16 weeks, and 24 weeks to compare outcomes between groups. The trial is conducted at Princess Margaret Cancer Centre within the University Health Network in Toronto.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced (stage IV or specified stage III for lung/pancreas) cancer, ECOG 0–2, an oncologist-estimated prognosis of 6–36 months, not already receiving specialized palliative care, and able to complete online symptom screening in English.
Not a fit: Patients with severe cognitive impairment, insufficient English literacy to complete questionnaires, or those already receiving specialist palliative care are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, STEP2 could preserve patient quality of life while focusing limited specialist palliative resources on those with the greatest symptom needs.
How similar studies have performed: Previous randomized trials have shown outpatient early palliative care improves quality of life in advanced cancer, but combining routine symptom screening with targeted referrals like STEP2 is a newer, less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Insufficient English literacy to complete study questionnaires * Severe cognitive deficit, as per treating oncologist * Receiving specialized palliative care
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Camilla Zimmermann, MD PhD — University Health Network, Toronto
- Study coordinator: Kathy Khorramak, BSc
- Email: katayoun.khorramak@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oncology