Clinical trial · Interventional
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID-19 pandemic
Summary
Brief summary (as posted)
Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner. The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symptom screening with Targeted Early Palliative Care (STEP) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Symptom screening with Targeted Early Palliative Care (STEP)
- description
- The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
- interventionNames
- Behavioral: Symptom screening with Targeted Early Palliative Care (STEP)
- type
- NO_INTERVENTION
- label
- Standard Oncology Care
- description
- The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit.
Primary outcomes (1)
- measure
- Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of stage IV cancer (advanced); hormone-refractory for breast or prostate cancer; stage III or IV for lung cancer and pancreatic cancer; patients with stage III cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist * ECOG performance status ≤ 2 (estimated by primary oncologist) * Prognosis of 6-36 months (estimated by primary oncologist) * Patient completes symptom screening in outpatient clinic electronically Exclusion Criteria: * Insufficient English literacy to complete questionnaires * Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score \<20 or \>10 errors) * Receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.
References
Publications (0)
Data not yet available