Pilot Trial of Virtual and In-person STEP2

NCT06326554 | Completed

• 1 other identifier: 22-5933
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic. Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months.

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• FACIT-PAL 14

  A 14-item version of the Functional Assessment of Chronic Illness Therapy (FACIT) scale, with items that are considered relevant for patients with advanced cancer. Scoring ranges from 0-56 with lower scores indicating better quality of life.

  6 months

Secondary Outcomes (6)

• FACIT-PAL 14

  2 and 4 months

• ESAS-r-CS

  2, 4, and 6 months

• PHQ-9

  2, 4, and 6 months

• FAMCARE-P16

  2, 4, and 6 months

• Generalized Anxiety Disorder-7

  2, 4, and 6 months

Study Arms (1)

STEP2

EXPERIMENTAL

Moderate-to-severe symptoms on the Edmonton Symptom Assessment System-revised (ESAS-r+) tool will trigger an email to the study team and the study triage nurse. The study triage nurse will review the scores via electronic medical record and call the patient within 2 business days to offer immediate advice by phone. During the phone call, the study triage nurse will offer to schedule a formal in-person or virtual palliative care clinic (PCC) visit. Participants agreeing to the PCC referral subsequently receive at least monthly in-person and/or virtual PCC follow-up visits until study end, based on patient needs and care provider preference.

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

Interventions

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

Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden.

STEP2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18+ years
• stage IV cancer (stage III or IV for lung or pancreas cancers; hormone-refractory for prostate and ER-positive breast cancers)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• oncologist-estimated prognosis of 6-36 months
• willingness to complete routine online symptom screening at the Princess Margaret Cancer Centre

You may not qualify if:

• insufficient English literacy to complete study procedures
• oncologist-determined poor cognitive status
• already received or currently receiving specialized palliative care

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Camilla Zimmermann, MD PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm intervention

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: March 27, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)