STEP2 versus routine early palliative care for people with advanced cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.