STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority Trial

Summary

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

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

Conditions2

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