NCT07446660

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
652

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Jul 2030

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

April 28, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

February 25, 2026

Last Update Submit

April 22, 2026

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)

    A 39-item measure consisting of the 27-item FACT-G subscale and the 12-item FACIT-Sp-12 subscale. Scores range from 0-4 per item with higher scores indicating worse quality of life.

    16 weeks

Secondary Outcomes (3)

  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)

    24 weeks

  • Family Satisfaction with Care - Patient Version (FAMCARE-P16)

    16 and 24 weeks

  • Mean Number of Outpatient Palliative Care Visits

    24 weeks

Other Outcomes (4)

  • Edmonton Symptom Assessment System-revised (ESAS-r-CS)

    16 and 24 weeks

  • Patient Health Questionnaire-9 (PHQ-9)

    16 and 24 weeks

  • Goals of Care Questionnaire (GOCQ)

    16 and 24 weeks

  • +1 more other outcomes

Study Arms (2)

STEP2

EXPERIMENTAL

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

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

Routine EPC

ACTIVE COMPARATOR

Automatically receives early palliative care referral.

Behavioral: Early Palliative Care (EPC)

Interventions

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

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.

STEP2
Early Palliative Care (EPC)BEHAVIORAL

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.

Routine EPC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Insufficient English literacy to complete study questionnaires
  • Severe cognitive deficit, as per treating oncologist
  • Receiving specialized palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Camilla Zimmermann, MD PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Khorramak, BSc

CONTACT

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

Samantha Lo, MSc

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

April 28, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)