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STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial

NCT07446660 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Interventions

BEHAVIORAL

Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)

Moderate-to-severe symptoms on the Edmonton Symptom Assessment System-revised (ESAS-r+) will trigger an alert to the study team and the study triage nurse. The triage nurse will review symptom scores and contact the patient within 2 business days to provide telephone advice. During the call, the nurse will offer to arrange an in-person or virtual palliative care clinic (PCC) visit. Participants who agree to a PCC referral will then receive at least monthly in-person and/or virtual PCC follow-up based on patient needs and provider preference, in addition to their usual oncology care.

BEHAVIORAL

Early Palliative Care (EPC)

Structured palliative care visits at least once per month soon after randomization. Visits may be conducted in-person or virtually and is delivered alongside usual oncology care.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Camilla Zimmermann, MD PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2030-05-31
Completion
2030-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446660 on ClinicalTrials.gov