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

NCT ID: NCT03987906

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2020-09-30

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Symptom screening with Targeted Early Palliative Care (STEP)

Intervention Type: BEHAVIORAL

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.

Standard Oncology Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 Type: BEHAVIORAL

Other Intervention Names

STEP

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Kingston Health Sciences Centre

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilla Zimmermann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

19-5007

Identifier Type: -

Identifier Source: org_study_id