Behaviors and Mental Disorders

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Quality of Life

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.

Symptom screening with Targeted Early Palliative care (STEP)

Camilla Zimmermann, MD, PhD

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.

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.

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

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

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.

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.

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.

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.

Depression is measured by the Patient Health Questionnaire (PHQ-9). Scores range from 0-27 with higher scores indicating worse depression.

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.

University Health Network, Toronto

The control arm receives standard oncology care, which includes routine symptom screening at every outpatient visit.

Symptom screening with Targeted Early Palliative Care (STEP)

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.

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.

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

Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer: A Randomized Controlled Trial

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 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 is measured by the Patient Health Questionnaire (PHQ-9). Total score ranges from 0-27, higher scores indicate worse depression.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer	NCT04044040	Cancer	Symptom screeni...	18 Years -	University Health Network, Toronto
Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer	NCT04044040	Cancer	Symptom screeni...	18 Years -	University Health Network, Toronto
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer	NCT03987906	Cancer	Symptom screeni...	18 Years -	University Health Network, Toronto
Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer	NCT03987906	Cancer	Symptom screeni...	18 Years -	University Health Network, Toronto

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