OncologySTEP2NCT06326554
Pilot Trial of Virtual and In-person STEP2
A study testing Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) in people with Oncology, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2025to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18+ years
- stage IV cancer (stage III or IV for lung or pancreas cancers; hormone-refractory for prostate and ER-positive breast cancers)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- oncologist-estimated prognosis of 6-36 months
- willingness to complete routine online symptom screening at the Princess Margaret Cancer Centre
Who cannot join
- insufficient English literacy to complete study procedures
- oncologist-determined poor cognitive status
- already received or currently receiving specialized palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm Pilot Trial of Virtual and In-person Symptom Screening With Targeted Early Palliative Care (STEP2)
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.
Read the detailed description
To improve equitable access to early palliative care based on symptom severity, the investigators developed Symptom screening with Targeted Early Palliative care (STEP) and demonstrated its feasibility in a previous trial. STEP was designed and tested before the COVID-19 pandemic and was based on symptom screening using tablets/computers in oncology clinics and in-person visits in the palliative care clinic. In response to changes in hospital care as a result of the COVID-19 pandemic, the investigators developed a novel, mixed in-person and virtually delivered intervention, 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. Participants will complete the Edmonton Symptom Assessment System-revised (ESAS-r+) tool electronically before oncology appointments (as is usual care in Ontario, Canada); in addition, if patients report moderate to high symptom scores, they will receive nurse-led triage and targeted referral to specialized palliative care. Quality of life, symptom burden, depression, anxiety and satisfaction with care will be assessed at baseline, 2, 4, and 6 months using questionnaires.
The objectives of this study are 1) to assess the feasibility of the STEP2 intervention, including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person; and 2) to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic.
- Conditions
- Oncology
- Being tested
- Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)Behavioural
Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden.
| Study group | Role | What they receive |
|---|---|---|
| STEP2 | Experimental | 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. Receives: Behavioral: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT-PAL 14
A 14-item version of the Functional Assessment of Chronic Illness Therapy (FACIT) scale, with items that are considered relevant for patients with advanced cancer. Scoring ranges from 0-56 with lower scores indicating better quality of life.
Measured: 6 months
Secondary outcomes (6)
FACIT-PAL 14
A 14-item version of the Functional Assessment of Chronic Illness Therapy (FACIT) scale, with items that are considered relevant for patients with advanced cancer. Scores range from 0-4 per item with higher scores indicating worse quality of life.
Measured: 2 and 4 months
ESAS-r-CS
Edmonton Symptom Assessment System-revised (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.
Measured: 2, 4, and 6 months
PHQ-9
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.
Measured: 2, 4, and 6 months
FAMCARE-P16
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.
Measured: 2, 4, and 6 months
Generalized Anxiety Disorder-7
A valid and brief 7-item Generalized Anxiety Disorder (GAD-7) tool measuring severity of anxiety in patients. Scores range from 0-3 per item with higher scores indicating worse anxiety.
Measured: 2, 4, and 6 months
Patient Global Impression of Change
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.
Measured: 2, 4, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start27 Mar 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Zimmermann, University Health Network, Toronto
- Investigators
- Camilla Zimmermann, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326554
- Sponsor's protocol ID
- 22-5933
- Acronym
- STEP2
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Pilot Trial of Virtual and In-person Symptom Screening With Targeted Early Palliative Care (STEP2)
- ClinicalTrials.gov ID
- NCT06326554
- Acronym / sponsor ID
- STEP2 / 22-5933
- Conditions
- Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To improve equitable access to early palliative care based on symptom severity, the investigators developed Symptom screening with Targeted Early Palliative care (STEP) and demonstrated its feasibility in a previous trial. STEP was designed and tested before the COVID-19 pandemic and was based on symptom screening using tablets/computers in oncology clinics and in-person visits in the palliative care clinic. In response to changes in hospital care as a result of the COVID-19 pandemic, the investigators developed a novel, mixed in-person and virtually delivered intervention, 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. Participants will complete the Edmonton Symptom Assessment System-revised (ESAS-r+) tool electronically before oncology appointments (as is usual care in Ontario, Canada); in addition, if patients report moderate to high symptom scores, they will receive nurse-led triage and targeted referral to specialized palliative care. Quality of life, symptom burden, depression, anxiety and satisfaction with care will be assessed at baseline, 2, 4, and 6 months using questionnaires.
The objectives of this study are 1) to assess the feasibility of the STEP2 intervention, including completion of virtual symptom screening before oncology clinic appointments and completing triggered palliative care visits by video as well as in person; and 2) to explore factors patients consider when deciding to accept or defer a visit to the outpatient palliative care clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm intervention
| Arm | Type | Receives |
|---|---|---|
| STEP2 | Experimental | Behavioral: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18+ years
- stage IV cancer (stage III or IV for lung or pancreas cancers; hormone-refractory for prostate and ER-positive breast cancers)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- oncologist-estimated prognosis of 6-36 months
- willingness to complete routine online symptom screening at the Princess Margaret Cancer Centre
Key exclusion criteria (3 listed)
- insufficient English literacy to complete study procedures
- oncologist-determined poor cognitive status
- already received or currently receiving specialized palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2)Study nurse will offer a palliative care clinic visit referral alongside usual cancer care to participants who report moderate to high symptom burden. | Behavioural | STEP2 |
Primary outcome
FACIT-PAL 14
Time frame: 6 months
A 14-item version of the Functional Assessment of Chronic Illness Therapy (FACIT) scale, with items that are considered relevant for patients with advanced cancer. Scoring ranges from 0-56 with lower scores indicating better quality of life.
6 secondary outcomes
FACIT-PAL 14
Time frame: 2 and 4 months
ESAS-r-CS
Time frame: 2, 4, and 6 months
PHQ-9
Time frame: 2, 4, and 6 months
FAMCARE-P16
Time frame: 2, 4, and 6 months
Generalized Anxiety Disorder-7
Time frame: 2, 4, and 6 months
Patient Global Impression of Change
Time frame: 2, 4, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Zimmermann, MD PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) in people with Oncology, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-PAL 14 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.