STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial
ConditionOncology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Insufficient English literacy to complete study questionnaires
Severe cognitive deficit, as per treating oncologist
Receiving specialized palliative care
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
BehavioralModerate-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.
Early Palliative Care (EPC)
BehavioralStructured 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.
Treatment groups
652 Participants
are divided into 2 treatment groupsGroup A: STEP2Experimental treatment 1 intervention
Group B: Routine EPCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
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.
Time frame
16 weeksSecondary outcomes
1
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
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.
Time frame
24 weeks2
Family Satisfaction with Care - Patient Version (FAMCARE-P16)
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.
Time frame
16 and 24 weeks3
Mean Number of Outpatient Palliative Care Visits
Time frame
24 weeksOther outcomes
1
Edmonton Symptom Assessment System-revised (ESAS-r-CS)
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.
Time frame
16 and 24 weeks2
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame
16 and 24 weeks3
Goals of Care Questionnaire (GOCQ)
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").
Time frame
16 and 24 weeks4
Patient Global Impression of Change (PGIC)
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.
Time frame
16 and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov