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

What You Need to Know Before You Apply

What is the purpose of this 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 and managing symptoms. It examines how patients with stage IV cancer (or stage III/IV for certain types) decide to accept or delay these referrals. Participants will complete surveys about their quality of life and satisfaction with care over several months. This trial suits those with advanced cancer who are open to completing regular online symptom check-ins. As an unphased trial, it offers a unique opportunity for patients to contribute to research that may enhance future care strategies.

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 prior data suggests that this protocol is safe for cancer patients?

Research has shown that the STEP2 treatment, which combines online and in-person symptom checks with early supportive care, is generally manageable for patients. In past studies, most patients completed a significant portion of their symptom checks. For instance, one study found that 77% of participants finished their screenings for most visits.

These studies revealed no major safety issues, suggesting the treatment is safe for individuals. The treatment focuses on managing symptoms and improving quality of life primarily through supportive care rather than medication, reducing the risk of side effects.

Overall, evidence indicates that STEP2 is a safe option for trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about STEP2 because it offers a fresh approach to managing cancer symptoms through both virtual and in-person care. Unlike traditional methods that often rely on scheduled clinic visits, STEP2 uses a proactive system where patients' symptom scores trigger immediate follow-up. This timely response means that patients can receive advice and care tailored to their needs much faster, potentially improving their quality of life. Additionally, the option for virtual follow-ups makes it more convenient for patients to receive consistent care, regardless of their location.

What evidence suggests that the STEP2 protocol is effective for cancer patients?

Research has shown that the STEP2 method, which includes both online and in-person symptom checks, can effectively identify patients with severe symptoms. In this trial, researchers will monitor participants using the STEP2 method to ensure timely palliative care, which studies have shown improves overall quality of life. Specifically, patients who received early palliative care managed their symptoms better and experienced less distress. The system aims to address symptoms early, providing support before they worsen. While individual results may vary, the STEP2 program shows promise in improving care for cancer patients with significant symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Camilla Zimmermann, MD PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06326554

NCT06326554 | Pilot Trial of Virtual and In-person STEP2 The objectives of this study are 1) to assess the feasibility of the STEP2 intervention, including completion of virtual symptom screening before oncology ...

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

Symptom screening with Targeted Early Palliative care ... We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2823624

Telehealth vs In-Person Early Palliative Care for Patients ... Rate of caregiver participation in visits was lower for video vs in-person early palliative care (36.6% vs 49.7%; P < .001). Study groups did ...

4. researchgate.net researchgate.net/publication/354447973_Phase_II_Trial_of_Symptom_Screening_With_Targeted_Early_Palliative_Care_for_Patients_With_Advanced_Cancer

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03987906?tab=table

Symptom Screening With Targeted Early Palliative Care ... The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden ...

6. researchgate.net researchgate.net/publication/367972586_Symptom_screening_with_Targeted_Early_Palliative_care_STEP_versus_usual_care_for_patients_with_advanced_cancer_A_mixed_methods_study

(PDF) Symptom screening with Targeted Early Palliative ... Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: A mixed methods study. January ...

7. 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 ...