Recruiting

STEP2

Sponsor:

University Health Network, Toronto

Code:

NCT07446660

Conditions

Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Early Palliative Care (EPC)

Study Details

Brief 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

Oncology

Study ID

NCT07446660

Start date

Mar 23, 2026

Status verified date

Feb, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

652 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: STEP2

Receives a referral only if they report moderate-to-severe symptoms.

active comparator: Routine EPC

Automatically receives early palliative care referral.

Interventions

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.

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.

Primary outcome measure

  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Kathy Khorramak, BSc

416-340-4800katayoun.khorramak@uhn.ca

Samantha Lo, MSc

416-340-4800samantha.lo@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

Contacts

Kathy Khorramak

416-340-4800step2@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 28, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-28.