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

Qualifiers

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

Treatments tested in this trial

  • Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
  • Early Palliative Care (EPC)

Treatment groups

652 Participants
are divided into 2 treatment groups