Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:37 AM
Study NCT ID:
NCT07446660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP2 RNT
Brief Summary:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: