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

Cancer Clinical Trial

Official title:

Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer: A Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04044040
• Other study ID #: REB ID 16-5590
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after enrollment
Secondary	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.	2 and 4 months after enrollment
Secondary	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.	2, 4 and 6 months after enrollment
Secondary	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.	2, 4 and 6 months after enrollment
Secondary	Depression	Depression is measured by the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating worse depression.	2, 4 and 6 months after enrollment
Secondary	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.	2, 4 and 6 months after enrollment