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

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ClinicalTrials.gov Identifier: NCT03987906
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Kingston Health Sciences Centre
Information provided by (Responsible Party):
University Health Network, Toronto

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 522 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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.



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987906


Contacts
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Contact: Camilla Zimmermann, MD, PhD 416-946-4501 ext 3477 camilla.zimmermann@uhn.ca
Contact: Ashley Pope, BSc 416-340-4800 ext 4426 ashley.pope@uhnresearch.ca

Locations
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Canada, Ontario
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Leonie Herx, MD, PhD    613-548-2485    Leonie.Herx@kingstonhsc.ca   
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Camilla Zimmermann, MD, PhD    416-946-4501 ext 3477    camilla.zimmermann@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Kingston Health Sciences Centre
Investigators
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Principal Investigator: Camilla Zimmermann, MD, PhD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03987906     History of Changes
Other Study ID Numbers: 19-5007
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Palliative Care
Symptom control
Quality of life
Satisfaction with care
Targeted referral
Randomized controlled trial