CancerNCT04044040
Symptom Screening With Targeted Early Palliative Care (STEP) 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 1 site 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
- 116 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Jul 2018
- 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 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
1 site in 1 country.
About this study
Official title: Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer: A Pilot 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.
We 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 single-arm trial at Princess Margaret Cancer Centre to determine the feasibility of a larger randomized trial of STEP versus usual care and to establish specific parameters for its planning.
Read the detailed description
Randomized controlled trials (RCTs) have shown 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.
Patients will be recruited from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics. Consenting participants will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The objectives of the study are to assess the feasibility of conducting a larger phase III trial and to collect information to assist in trial planning and sample size calculation for such a trial. Feasibility criteria are: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint.
- 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
- 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
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) |
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 FACIT-Sp.
The FACIT-Sp encompasses the FACT-G (Functional Assessment of Cancer Therapy-General) and FACIT spiritual well-being subscale to measure physical, social/family, emotional, functional and existential well-being.
Measured: 6 months after enrollment
Secondary outcomes (5)
Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp.
The FACIT-Sp encompasses the FACT-G (Functional Assessment of Cancer Therapy-General) and FACIT spiritual well-being subscale to measure physical, social/family, emotional, functional and existential well-being. Scores range from 0-156 with higher scores indicating better quality of life.
Measured: 2 and 4 months after enrollment
Patient Heath Related Quality of Life (HRQL) as measured by the QUAL-E.
The QUAL-E (Quality of Life at the End of Life) measures quality of life domains including life completion, symptoms impact, relationship with health care provider, and preparation for end of life. Scores range from 21-105 with higher scores indicating better quality of life.
Measured: 2, 4 and 6 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). All 11 items are summed for the ESAS-r-CS Total Distress Score (TDS), where 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). Scores range from 0-27 with higher scores indicating 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). Scores range from 16-80 with higher scores indicating higher 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 posted2 Aug 2019
- Study startSep 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camilla Zimmermann, MD, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044040
- Sponsor's protocol ID
- REB ID 16-5590
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmermann C, Pope A, Hannon B, Krzyzanowska MK, Rodin G, Li M, Howell D, Knox JJ, Leighl NB, Sridhar S, Oza AM, Prince R, Lheureux S, Hansen AR, Rydall A, Chow B, Herx L, Booth CM, Dudgeon D, Dhani N, Liu G, Bedard PL, Mathews J, Swami N, Le LW. Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer. J Natl Compr Canc Netw. 2021 Sep 7;20(4):361-370.e3. doi: 10.6004/jnccn.2020.7803.
PubMed 34492632
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04044040
- Acronym / sponsor ID
- REB ID 16-5590
- Conditions
- Cancer
- Keywords
- Palliative care, Symptom control, Quality of life, Satisfaction with care, Targeted referral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Aug 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.
We 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 single-arm trial at Princess Margaret Cancer Centre to determine the feasibility of a larger randomized trial of STEP versus usual care and to establish specific parameters for its planning.
Detailed description
Randomized controlled trials (RCTs) have shown 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.
Patients will be recruited from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics. Consenting participants will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The objectives of the study are to assess the feasibility of conducting a larger phase III trial and to collect information to assist in trial planning and sample size calculation for such a trial. Feasibility criteria are: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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. |
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 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)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. | Behavioural | Symptom screening with Targeted Early Palliative care (STEP) |
Primary outcome
Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp.
Time frame: 6 months after enrollment
The FACIT-Sp encompasses the FACT-G (Functional Assessment of Cancer Therapy-General) and FACIT spiritual well-being subscale to measure physical, social/family, emotional, functional and existential well-being.
5 secondary outcomes
Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp.
Time frame: 2 and 4 months after enrollment
Patient Heath Related Quality of Life (HRQL) as measured by the QUAL-E.
Time frame: 2, 4 and 6 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 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 28 Aug 2024.
- Derived from this study: PubMed 34492632Zimmermann C, Pope A, Hannon B, Krzyzanowska MK, Rodin G, Li M, Howell D, Knox JJ, Leighl NB, Sridhar S, Oza AM, Prince R, Lheureux S, Hansen AR, Rydall A, Chow B, Herx L, Booth CM, Dudgeon D, Dhani N, Liu G, Bedard PL, Mathews J, Swami N, Le LW. Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer. J Natl Compr Canc Netw. 2021 Sep 7;20(4):361-370.e3. doi: 10.6004/jnccn.2020.7803.
- 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 Symptom screening with Targeted Early Palliative care (STEP) in people with Cancer, 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 28 Aug 2024. 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?
Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp. (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?
On the ClinicalTrials.gov record for NCT04044040, which also lists 1 linked publication.
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 28 Aug 2024.