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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 652}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Edmonton Symptom Assessment System-revised (ESAS-r-CS)', 'timeFrame': '16 and 24 weeks', 'description': '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.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '16 and 24 weeks', 'description': '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.'}, {'measure': 'Goals of Care Questionnaire (GOCQ)', 'timeFrame': '16 and 24 weeks', 'description': 'A 5-item measure that addresses patients\' perception of goals of care and end-of-life care communication with their clinicians. Our dichotomous outcomes will include: patients\' most important perceived goal related to their cancer treatment ("to cure my cancer" vs. "other"); perception of the treatability or curability of their cancer ("my cancer can be cured" vs. "other"); and having discussed their future end-of-life care wishes with their clinician ("yes" vs. "no").'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': '16 and 24 weeks', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)', 'timeFrame': '16 weeks', 'description': 'A 39-item measure consisting of the 27-item FACT-G subscale and the 12-item FACIT-Sp-12 subscale. Scores range from 0-4 per item with higher scores indicating worse quality of life.'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)', 'timeFrame': '24 weeks', 'description': 'A 39-item measure consisting of the 27-item FACT-G subscale and the 12-item FACIT-Sp-12 subscale. Scores range from 0-4 per item with higher scores indicating worse quality of life.'}, {'measure': 'Family Satisfaction with Care - Patient Version (FAMCARE-P16)', 'timeFrame': '16 and 24 weeks', 'description': '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.'}, {'measure': 'Mean Number of Outpatient Palliative Care Visits', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Stage IV cancer (endocrine-resistant ER+ breast and castration-resistant prostate cancer; stage 3 included for lung or pancreatic cancer)\n* Oncologist-estimated Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Oncologist-estimated prognosis of 6-36 months\n* Willingness to complete virtual ESAS-r+ screening before each appointment\n\nExclusion Criteria:\n\n* Insufficient English literacy to complete study questionnaires\n* Severe cognitive deficit, as per treating oncologist\n* Receiving specialized palliative care'}, 'identificationModule': {'nctId': 'NCT07446660', 'acronym': 'STEP2 RNT', 'briefTitle': 'STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial', 'orgStudyIdInfo': {'id': '25-5376'}}, 'armsInterventionsModule': {'armGroups': [{'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)']}], 'interventions': [{'name': 'Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)', 'type': 'BEHAVIORAL', 'description': '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 based on patient needs and provider preference, in addition to their usual oncology care.', 'armGroupLabels': ['STEP2']}, {'name': 'Early Palliative Care (EPC)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Routine EPC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kathy Khorramak, BSc', 'role': 'CONTACT', 'email': 'katayoun.khorramak@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '4426'}, {'name': 'Samantha Lo, MSc', 'role': 'CONTACT', 'email': 'samantha.lo@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '4426'}], 'overallOfficials': [{'name': 'Camilla Zimmermann, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Camilla Zimmermann', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}