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出境医 / 临床实验 / Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer (STEP)

Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer (STEP)

Study Description
Brief 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 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.


Condition or disease Intervention/treatment Phase
Cancer Behavioral: Symptom screening with Targeted Early Palliative Care (STEP) Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
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.
Other Name: STEP

No Intervention: Standard Oncology Care
The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. [ Time Frame: 2 and 4 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.

  2. Symptom control [ Time Frame: 2, 4 and 6 months after enrollment ]
    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.

  3. Depression [ Time Frame: 2, 4, and 6 months after enrollment ]
    Depression is measured by the Patient Health Questionnaire (PHQ-9). Total score ranges from 0-27, higher scores indicate worse depression.

  4. Patient satisfaction with care. [ Time Frame: 2, 4, and 6 months after enrollment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations

Locations
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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Kingston Health Sciences Centre
Investigators
Layout table for investigator information
Principal Investigator: Camilla Zimmermann, MD, PhD University Health Network, Toronto
Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE August 8, 2019
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. [ Time Frame: 2 and 4 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.
  • Symptom control [ Time Frame: 2, 4 and 6 months after enrollment ]
    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.
  • Depression [ Time Frame: 2, 4, and 6 months after enrollment ]
    Depression is measured by the Patient Health Questionnaire (PHQ-9). Total score ranges from 0-27, higher scores indicate worse depression.
  • Patient satisfaction with care. [ Time Frame: 2, 4, and 6 months after enrollment ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7. [ Time Frame: 2 and 4 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.
  • Symptom control [ Time Frame: 2, 4 and 6 months after enrollment ]
    Symptom control is measured by the 11-item ESAS-r-CS (Edmonton Symptom Assessment System-revised plus constipation and trouble sleeping).
  • Depression [ Time Frame: 2, 4, and 6 months after enrollment ]
    Depression is measured by the Patient Health Questionnaire (PHQ-9).
  • Patient satisfaction with care. [ Time Frame: 2, 4, and 6 months after enrollment ]
    Satisfaction with care is measured by the FAMCARE-P16 (Family Satisfaction with Cancer Scale modified for patients).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer
Official Title  ICMJE Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE 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.
Other Name: STEP
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Symptom screening with Targeted Early Palliative Care (STEP)
  • No Intervention: Standard Oncology Care
    The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 16, 2021)
69
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
522
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987906
Other Study ID Numbers  ICMJE 19-5007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Kingston Health Sciences Centre
Investigators  ICMJE
Principal Investigator: Camilla Zimmermann, MD, PhD University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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