Clinical trial · Interventional
STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early Palliative Care (EPC) | Behavioral | — | UNRESOLVED |
| Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- STEP2
- description
- Receives a referral only if they report moderate-to-severe symptoms.
- interventionNames
- Behavioral: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
- type
- ACTIVE_COMPARATOR
- label
- Routine EPC
- description
- Automatically receives early palliative care referral.
- interventionNames
- Behavioral: Early Palliative Care (EPC)
Primary outcomes (1)
- measure
- Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available