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Trial record 1 of 1 for:    NCT04044040
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Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT04044040
Recruitment Status : Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : April 12, 2022
Sponsor:
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.

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer: A Pilot Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2023

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp. [ Time Frame: 2 and 4 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. Scores range from 0-156 with higher scores indicating better quality of life.

  2. Patient Heath Related Quality of Life (HRQL) as measured by the QUAL-E. [ Time Frame: 2, 4 and 6 months after enrollment ]
    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.

  3. 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). All 11 items are summed for the ESAS-r-CS Total Distress Score (TDS), where higher scores indicate worse symptom burden.

  4. Depression [ Time Frame: 2, 4 and 6 months after enrollment ]
    Depression is measured by the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating worse depression.

  5. 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). Scores range from 16-80 with higher scores indicating higher satisfaction with care.



Information from the National Library of Medicine

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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 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): NCT04044040


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Camilla Zimmermann, MD, PhD University Health Network, Toronto
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04044040    
Other Study ID Numbers: REB ID 16-5590
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
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