Clinical trial NCT06326554: Pilot Trial of Virtual and In-person STEP2
Official title: Single Arm Pilot Trial of Virtual and In-person Symptom Screening With Targeted Early Palliative Care (STEP2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm intervention
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: To improve equitable access to early palliative care based on symptom severity, the investigators 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, the investigators developed a novel, mixed in-person and virtually delivered intervention, STEP2.

The investigators 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 Edmonton Symptom Assessment System-revised (ESAS-r+) tool 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: FACIT-PAL 14
timeFrame: 6 months
Secondary outcomes:
measure: FACIT-PAL 14
timeFrame: 2 and 4 months
measure: ESAS-r-CS
timeFrame: 2, 4, and 6 months
measure: PHQ-9
timeFrame: 2, 4, and 6 months
measure: FAMCARE-P16
timeFrame: 2, 4, and 6 months
measure: Generalized Anxiety Disorder-7
timeFrame: 2, 4, and 6 months
measure: Patient Global Impression of Change
timeFrame: 2, 4, and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Camilla Zimmermann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: