CancerSTEPNCT03987906
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer
A study testing Symptom screening with Targeted Early Palliative Care (STEP) in people with Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Symptom screening with Targeted Early Palliative Care (STEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesCanada
- Study dates
- 8 Aug 2019to 30 Sep 2020
- 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
- Diagnosis of stage IV cancer (advanced); hormone-refractory for breast or prostate cancer; stage III or IV for lung cancer and pancreatic cancer; patients with stage III cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist
- ECOG performance status ≤ 2 (estimated by primary oncologist)
- Prognosis of 6-36 months (estimated by primary oncologist)
- Patient completes symptom screening in outpatient clinic electronically
Who cannot join
- Insufficient English literacy to complete questionnaires
- Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score <20 or >10 errors)
- Receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
About this study
Official title: Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial
Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner.
The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics.
Read the detailed description
Randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable.
Consenting patients from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics will be assigned randomly either to receive STEP or to follow usual symptom screening. All patients will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The investigators will measure the impact of STEP on these outcomes, compared to screening alone.
- Conditions
- Cancer
- Being tested
- Symptom screening with Targeted Early Palliative Care (STEP)
- Keywords
- Palliative Care, Symptom control, Quality of life, Satisfaction with care, Targeted referral, Randomized controlled trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom screening with Targeted Early Palliative Care (STEP)Behavioural
Also called STEP
The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
| Study group | Role | What they receive |
|---|---|---|
| Symptom screening with Targeted Early Palliative Care (STEP) | Experimental | The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team. Receives: Behavioral: Symptom screening with Targeted Early Palliative Care (STEP) |
| Standard Oncology Care | No intervention | The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.
The FACT-G7 (Functional Assessment of Cancer Therapy-General 7 item) is a 7-item measure for quality of life that has been validated in patients with advanced cancer. Total score ranges from 0-28, higher scores indicate better quality of life.
Measured: 6 months after enrollment.
Secondary outcomes (4)
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.
The FACT-G7 (Functional Assessment of Cancer Therapy-General 7 item) is a 7-item measure for quality of life that has been validated in patients with advanced cancer. Total score ranges from 0-28, higher scores indicate better quality of life.
Measured: 2 and 4 months after enrollment
Symptom control
Symptom control is measured by the 11-item ESAS-r-CS (Edmonton Symptom Assessment System-revised plus constipation and trouble sleeping). ESAS total distress score ranges from 0-110, higher scores indicate worse symptom burden.
Measured: 2, 4 and 6 months after enrollment
Depression
Depression is measured by the Patient Health Questionnaire (PHQ-9). Total score ranges from 0-27, higher scores indicate worse depression.
Measured: 2, 4, and 6 months after enrollment
Patient satisfaction with care.
Satisfaction with care is measured by the FAMCARE-P16 (Family Satisfaction with Cancer Scale modified for patients). Total score ranges from 16-80, higher scores indicate greater satisfaction with care.
Measured: 2, 4, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start8 Aug 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Kingston Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Camilla Zimmermann, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987906
- Sponsor's protocol ID
- 19-5007
- Acronym
- STEP
- Status last verified
- May 2022
- First submitted
- 13 Jun 2019
- Last updated
- 23 May 2022
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03987906
- Acronym / sponsor ID
- STEP / 19-5007
- Conditions
- Cancer
- Keywords
- Palliative Care, Symptom control, Quality of life, Satisfaction with care, Targeted referral, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Kingston Health Sciences Centre
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 17 Jun 2019 (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.
Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner.
The investigators have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a multi-center trial at Princess Margaret Cancer Centre and Kingston General Hospital to compare STEP with usual symptom screening in medical oncology clinics.
Detailed description
Randomized controlled trials have shown that when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable.
Consenting patients from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics will be assigned randomly either to receive STEP or to follow usual symptom screening. All patients will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The investigators will measure the impact of STEP on these outcomes, compared to screening alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom screening with Targeted Early Palliative Care (STEP) | Experimental | Behavioral: Symptom screening with Targeted Early Palliative Care (STEP)The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team. |
| Standard Oncology Care | No intervention | –The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit. |
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
- Diagnosis of stage IV cancer (advanced); hormone-refractory for breast or prostate cancer; stage III or IV for lung cancer and pancreatic cancer; patients with stage III cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist
- ECOG performance status ≤ 2 (estimated by primary oncologist)
- Prognosis of 6-36 months (estimated by primary oncologist)
- Patient completes symptom screening in outpatient clinic electronically
Key exclusion criteria (3 listed)
- Insufficient English literacy to complete questionnaires
- Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score <20 or >10 errors)
- Receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.
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 |
|---|---|---|
| Symptom screening with Targeted Early Palliative Care (STEP)Also: STEPThe experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team. | Behavioural | Symptom screening with Targeted Early Palliative Care (STEP) |
Primary outcome
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.
Time frame: 6 months after enrollment.
The FACT-G7 (Functional Assessment of Cancer Therapy-General 7 item) is a 7-item measure for quality of life that has been validated in patients with advanced cancer. Total score ranges from 0-28, higher scores indicate better quality of life.
4 secondary outcomes
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.
Time frame: 2 and 4 months after enrollment
Symptom control
Time frame: 2, 4 and 6 months after enrollment
Depression
Time frame: 2, 4, and 6 months after enrollment
Patient satisfaction with care.
Time frame: 2, 4, and 6 months after enrollment
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom screening with Targeted Early Palliative Care (STEP) in people with Cancer, run by University Health Network, Toronto at 2 sites 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: stopped early, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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?
Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. (time frame: 6 months after enrollment.). 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 23 May 2022.