Pilot Trial of Virtual and In-person STEP2

Oncology Clinical Trial

— STEP2  

Official title:

Single Arm Pilot Trial of Virtual and In-person Symptom Screening With Targeted Early Palliative Care (STEP2)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326554
• Other study ID #: 22-5933
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: Ashley Pope, BSc
• Phone: 416-340-4800
• Email: ashley.pope[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Behavioral:
• Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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. Scores range from 0-4 per item with higher scores indicating worse quality of life.	2 and 4 months
Secondary	ESAS-r-CS	Edmonton Symptom Assessment System-revised (ESAS-r-CS) measure with eleven scales with anchors of 0 (best) and 10 (worst) for pain, fatigue, drowsiness, nausea, anxiety, depression, appetite, dyspnea, well-being, constipation and sleep.	2, 4, and 6 months
Secondary	PHQ-9	A 9-item Patient Health Questionnaire (PHQ-9) for screening, diagnosing and monitoring the severity of depression. Scores range from 0-3 per item with higher scores indicating worse depression.	2, 4, and 6 months
Secondary	FAMCARE-P16	Modified family caregiver (FAMCARE) scale measuring patient satisfaction with information-giving, availability of care, psychological care and physical patient care in patients with advanced cancer. Scores range from 1-5 per item with higher scores indicating greater satisfaction.	2, 4, and 6 months
Secondary	Generalized Anxiety Disorder-7	A valid and brief 7-item Generalized Anxiety Disorder (GAD-7) tool measuring severity of anxiety in patients. Scores range from 0-3 per item with higher scores indicating worse anxiety.	2, 4, and 6 months
Secondary	Patient Global Impression of Change	A single-item patient-reported measure assessing change in health status and efficacy of an intervention, and is a widely used clinically relevant tool across many health conditions. The scale ranges from 1-7 and higher scores indicate worse change in health status.	2, 4, and 6 months