Single Arm Pilot Trial of Virtual & In-person STEP2

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

To improve equitable access to early palliative care based on symptom severity, we developed Symptom screening with Targeted Early Palliative care (STEP) and demonstrated its feasibility in a previous trial. STEP was designed and tested before the COVID-19 pandemic and was based on symptom screening using tablets/computers in oncology clinics and in-person visits in the palliative care clinic. In response to changes in hospital care as a result of the COVID-19 pandemic, our team has developed a novel, mixed in-person and virtually delivered intervention, STEP2. We propose to test STEP2 in a single-arm pilot trial, enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years. Participants will complete the ESAS-r+ electronically before oncology appointments (as is usual care in Ontario, Canada); in addition, if patients report moderate to high symptom scores, they will receive nurse-led triage and targeted referral to specialized palliative care. Quality of life, symptom burden, depression, anxiety and satisfaction with care will be assessed at baseline, 2, 4, and 6 months using questionnaires. The objectives of this study are 1) to assess the feasibility of the STEP2 intervention, including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person; and 2) to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06326554
Study type	Interventional
Source	University Health Network, Toronto
Contact	Ashley Pope, BSc
Phone	416-340-4800
Email	ashley.pope@uhn.ca
Status	Not yet recruiting
Phase	N/A
Start date	April 1, 2024
Completion date	January 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Single Arm Pilot Trial of Virtual and In-person STEP2 — STEP2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms