Virtual and In-Person STEP2 for Cancer

(STEP2 Trial)

Overseen By Samantha Lo, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Poor cognitive status, Specialized palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on symptom screening and palliative care referrals, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) for cancer?

The RELIEF study showed that using a digital tool for remote symptom reporting in cancer patients helped avoid emergency department visits, suggesting that regular symptom monitoring and timely intervention can improve patient outcomes. Additionally, early palliative care has been shown to improve quality of life for patients with advanced cancer, supporting the potential effectiveness of the STEP2 approach. ^{1 2 3 4 5}

Is the Virtual and In-Person STEP2 for Cancer treatment safe for humans?

The available research does not provide specific safety data for the Virtual and In-Person STEP2 for Cancer treatment, but related studies on symptom screening and palliative care tools suggest they are generally feasible and acceptable for patients. ^{1 2 5 6 7}

How does the STEP2 treatment for cancer differ from other treatments?

The STEP2 treatment for cancer is unique because it combines virtual and in-person palliative care, allowing for flexible and personalized symptom management. This approach can improve quality of life by providing timely support and reducing unnecessary hospital visits, which is particularly beneficial during situations like the COVID-19 pandemic. ^{2 4 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic. Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months.

Research Team

Camilla Zimmermann, MD PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults over 18 with advanced stage IV cancer, or specific cases of stage III lung or pancreas cancers, hormone-refractory prostate and ER-positive breast cancers. They should be able to perform daily activities (ECOG status 0-2) and have an estimated prognosis of 6-36 months. Participants must be willing to do online symptom screenings.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Symptom Screening and Triage

Participants complete the ESAS-r+ tool electronically before oncology appointments. Moderate-to-severe symptoms trigger a nurse-led triage and targeted referral to specialized palliative care.

6 months

Monthly in-person and/or virtual visits

Follow-up

Participants are monitored for quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months using questionnaires.

6 months

Questionnaires at baseline, 2, 4, and 6 months

Treatment Details

Interventions

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

Trial Overview The study tests a virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) approach before oncology appointments. It aims to see if this method helps patients decide on visiting the palliative care clinic and how it affects their quality of life, symptoms, mental health, and satisfaction over six months.

Participant Groups

Group I: STEP2 Experimental Treatment 1 Intervention

Moderate-to-severe symptoms on the Edmonton Symptom Assessment System-revised (ESAS-r+) tool will trigger an email to the study team and the study triage nurse. The study triage nurse will review the scores via electronic medical record and call the patient within 2 business days to offer immediate advice by phone. During the phone call, the study triage nurse will offer to schedule a formal in-person or virtual palliative care clinic (PCC) visit. Participants agreeing to the PCC referral subsequently receive at least monthly in-person and/or virtual PCC follow-up visits until study end, based on patient needs and care provider preference.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a pilot study involving 27 community palliative care patients, a high prevalence of symptomatic events was observed, with an average rate of 0.87 events per participant per day, highlighting the significant burden of symptoms in this population.

The study demonstrated that collecting data on patient-reported symptomatic events is both feasible and acceptable, suggesting that a larger, fully powered study could effectively assess the impact of medications on symptom burden in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic Events in a Community Palliative Care Population: A Prospective Pilot Study. To, THM., Collier, A., Agar, MR., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer patient-reported outcomes assessment using wireless touch screen tablet computers. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

RELIEF: A Digital Health Tool for the Remote Self-Reporting of Symptoms in Patients with Cancer to Address Palliative Care Needs and Minimize Emergency Department Visits. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Comfort app prototype: introducing a web-based application for monitoring comfort in palliative care. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: a mixed methods study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Symptomatic Events in a Community Palliative Care Population: A Prospective Pilot Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Real-Time Inpatient Palliative Care Screening Process to Promote Earlier Palliative Care Referrals. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Harnessing New and Existing Virtual Platforms to Meet the Demand for Increased Inpatient Palliative Care Services During the COVID-19 Pandemic: A 5 Key Themes Literature Review of the Characteristics and Barriers of These Evolving Technologies. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Telehealth outpatient palliative care in the COVID-19 pandemic: patient experience qualitative study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

1-2-3 Project: A Quality Improvement Initiative to Normalize and Systematize Palliative Care for All Patients With Cancer in the Outpatient Clinic Setting. [2021]