NCT03987906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 8, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

June 13, 2019

Last Update Submit

May 17, 2022

Conditions

Cancer

Keywords

Palliative CareSymptom controlQuality of lifeSatisfaction with careTargeted referralRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.

    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.

    6 months after enrollment.

Secondary Outcomes (4)

  • Patient Heath Related Quality of Life (HRQL) as measured by the FACT-G7.

    2 and 4 months after enrollment

  • Symptom control

    2, 4 and 6 months after enrollment

  • Depression

    2, 4, and 6 months after enrollment

  • Patient satisfaction with care.

    2, 4, and 6 months after enrollment

Study Arms (2)

Symptom screening with Targeted Early Palliative Care (STEP)

EXPERIMENTAL

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)

Standard Oncology Care

NO INTERVENTION

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

Interventions

Symptom screening with Targeted Early Palliative Care (STEP)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.

Also known as: STEP
Symptom screening with Targeted Early Palliative Care (STEP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Camilla Zimmermann, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

August 8, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)