652 Participants NeededMy employer runs this trial

STEP2 for Cancer

(STEP2 RNT Trial)

SL
KK
Overseen ByKathy Khorramak, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to provide palliative care, enhancing the quality of life for people with advanced cancer. The study explores two options: early palliative care referrals for everyone or a new system called STEP2 (Virtual and in-person Symptom screening with Targeted Early Palliative care), where referrals occur only if a patient reports moderate to severe symptoms. The researchers aim to determine if STEP2 is as effective as routine care by monitoring patients' well-being and satisfaction over time. People with advanced-stage cancer who experience significant symptoms and are open to online symptom checks might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies that could improve quality of life for future patients.

Do I need to stop my current medications for the STEP2 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the STEP2 system is safe for patients with advanced cancer?

Research has shown that STEP2, which involves checking symptoms and providing specific supportive care, is safe. In earlier studies, most patients completed the symptom checks, with many doing so regularly over several visits. This indicates that the process is generally manageable for patients.

Although the studies do not report specific negative effects from STEP2, the high completion rate suggests that patients do not experience major issues from the checks or subsequent care. Additionally, other research on telehealth palliative care, a component of STEP2, has found it to be as effective as in-person doctor visits, confirming the safety and efficacy of the online component.

Since STEP2 builds on existing palliative care methods, which are widely used and known for their safety, participants can feel confident about its safety.12345

Why are researchers excited about this trial?

Researchers are excited about the STEP2 protocol because it offers a more personalized approach to palliative care for cancer patients. Unlike standard early palliative care, which automatically refers patients for extra support, STEP2 only activates when patients report moderate-to-severe symptoms. This targeted method could ensure that resources are directed more efficiently, potentially improving quality of life for those who need it most. By combining virtual and in-person symptom screenings, STEP2 also provides a flexible, accessible way for patients to receive care tailored to their current needs.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that the STEP2 system, a treatment option in this trial, might improve the quality of life for people with advanced cancer. In an earlier study, 77% of patients regularly used the symptom screening tool, and more than half of those with severe symptoms received specialized care to ease their discomfort. This method targets those in greatest need by referring only patients with significant symptoms. Early results suggest that STEP2 is practical and well-received by patients, showing potential for identifying those who would benefit from early supportive care. While more information is needed, it offers a focused way to manage symptoms and improve patient satisfaction. Meanwhile, the Routine Early Palliative Care (EPC) arm automatically provides early palliative care referrals, offering a different approach to managing patient needs.12346

Who Is on the Research Team?

CZ

Camilla Zimmermann, MD PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced cancer—specifically stage IV, or stage III for lung or pancreatic cancer—who are expected to live 6–36 months and can complete online symptom check-ins before appointments. Participants need to be well enough to care for themselves most of the time.

Inclusion Criteria

My cancer is at stage IV, or stage III if I have lung or pancreatic cancer.
My doctor says I am able to care for myself and be active most of the day.
* Oncologist-estimated prognosis of 6-36 months
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants are randomly assigned to either routine EPC or STEP2, with symptom screening and palliative care referrals as per group assignment

24 weeks
Regular visits (in-person and virtual)

Follow-up

Participants are monitored for quality of life, satisfaction, symptoms, depression, and goals of care outcomes

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study compares two ways of providing early palliative care: one group gets routine referrals to a specialist team, while the other uses an online system (STEP2) that refers patients only if they report moderate-to-severe symptoms. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: STEP2Experimental Treatment1 Intervention
Group II: Routine EPCActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37341839/

Symptom screening with Targeted Early Palliative care ...

Despite lack of power for this halted trial, preliminary results favored STEP and qualitative results demonstrated acceptability.

NCT06326554 | Pilot Trial of Virtual and In-person STEP2

The investigators propose to test STEP2 in a single-arm pilot trial, enrolling outpatients with advanced cancer and a prognosis of 6 months to 3 years.

Phase II Trial of Symptom Screening With Targeted Early ...

Results: In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 (56%) received ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34492632/

Phase II Trial of Symptom Screening With Targeted Early ...

Results: In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 ...

Virtual and In-Person STEP2 for Cancer (STEP2 Trial)

This trial explores whether virtual symptom screening can help refer cancer patients to a palliative care clinic, which focuses on improving quality of life ...

Phase 2 trial of Symptom screening with Targeted Early ...

Measure completion was 79% (81/116) at 2, 61% (71/116) at 4, and 57% (66/116) at 6 months. By trial end (6 months), patients who received a call and accepted ...