STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial

Official title

Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial

Overview

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.

Detailed description

Palliative care (PC) is provided by a team of specialists focused on improving quality of life (QOL) for patients with advanced illness by offering symptom management and additional support for the patient and their caregivers. Studies have shown that early integration of PC (EPC) in an outpatient setting for patients with advanced cancer improved their QOL and overall satisfaction with care. Despite research proving the benefits of EPC, patients with the greatest need are not often referred to outpatient palliative care clinics due to resource restraints. Routine screening for symptom burden is recommended in clinical practice guidelines and can identify patients with the greatest need for EPC. In Ontario, Canada symptom screening is performed before every outpatient visit at all cancer centers. However, there has been no system that combines symptom screening with targeted EPC.

The investigators developed a system that combines routine symptom screening with targeted early palliative care (STEP); the latest version, STEP2, includes both in-person and virtual care, to reflect current practice. Patients are eligible to participate if they have advanced cancer, a prognosis of 6-36 months, good functional status, and can complete the online symptom screening. Enrolled patients will be randomly assigned to either the routine EPC or STEP2 groups. The STEP2 group will continue to complete routine symptom screening before their oncology visits and will only receive an outpatient palliative care clinic referral if they record a moderate-to-severe symptom score. The EPC group will automatically receive an outpatient palliative care clinic referral regardless of symptom scores. All patients will complete questionnaires evaluating QOL, satisfaction with care, symptom control, depression, and goals of care outcomes at recruitment, 16 weeks, and 24 weeks.

The investigators will review the measures for the STEP2 and EPC groups to determine whether STEP2 is as good as receiving routine EPC. Results from this study could provide access to palliative care for those patients who most need it, thereby improving their quality of life.

Interventions

• Behavioral Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
  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
• Behavioral Early Palliative Care (EPC)
  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.

Primary outcome measures

• Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [Time frame: 16 weeks]

Secondary outcome measures (3)

• Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [Time frame: 24 weeks]
• Family Satisfaction with Care - Patient Version (FAMCARE-P16) [Time frame: 16 and 24 weeks]
• Mean Number of Outpatient Palliative Care Visits [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT07446660 · 25-5376

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗