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

NCT04044040 | Completed

• 1 other identifier: REB ID 16-5590
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Palliative care; Symptom control; Quality of life; Satisfaction with care; Targeted referral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  2 and 4 months after enrollment

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

  2, 4 and 6 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 (1)

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)

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.

Symptom screening with Targeted Early Palliative care (STEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Related Publications (1)

• Zimmermann C, Pope A, Hannon B, Krzyzanowska MK, Rodin G, Li M, Howell D, Knox JJ, Leighl NB, Sridhar S, Oza AM, Prince R, Lheureux S, Hansen AR, Rydall A, Chow B, Herx L, Booth CM, Dudgeon D, Dhani N, Liu G, Bedard PL, Mathews J, Swami N, Le LW. Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer. J Natl Compr Canc Netw. 2021 Sep 7;20(4):361-370.e3. doi: 10.6004/jnccn.2020.7803.

  PMID: 34492632 DERIVED

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 2, 2019
• Study Start: September 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)