Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07446660

STEP2 vs. Routine Early Palliative Care: Randomized Noninferiority 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location status: Recruiting

Location contact

Kathy Khorramak

CONTACT

[email protected]

416-340-4800 ext. 4426

About this study

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.

The 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.

The 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Early Palliative Care (EPC)

Behavioral

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.

Primary outcomes

  1. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)

    Time frame: 16 weeks

    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.

Secondary outcomes

  1. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)

    Time frame: 24 weeks

    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.

  2. Family Satisfaction with Care - Patient Version (FAMCARE-P16)

    Time frame: 16 and 24 weeks

    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.

  3. Mean Number of Outpatient Palliative Care Visits

    Time frame: 24 weeks

Other outcomes

  1. Edmonton Symptom Assessment System-revised (ESAS-r-CS)

    Time frame: 16 and 24 weeks

    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.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 16 and 24 weeks

    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.

  3. Goals of Care Questionnaire (GOCQ)

    Time frame: 16 and 24 weeks

    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").

  4. Patient Global Impression of Change (PGIC)

    Time frame: 16 and 24 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Khorramak, BSc

CONTACT

[email protected]

416-340-4800 ext. 4426

Samantha Lo, MSc

CONTACT

[email protected]

416-340-4800 ext. 4426

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial

Acronym: STEP2 RNT

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 3, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.