Clinical trial NCT04044040: Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer
Official title: Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Palliative care
Symptom control
Quality of life
Satisfaction with care
Targeted referral
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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 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.

Primary outcomes:
measure: Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp.
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: Patient Heath Related Quality of Life (HRQL) as measured by the FACIT-Sp.
timeFrame: 2 and 4 months after enrollment
measure: Patient Heath Related Quality of Life (HRQL) as measured by the QUAL-E.
timeFrame: 2, 4 and 6 months after enrollment
measure: Symptom control
timeFrame: 2, 4 and 6 months after enrollment
measure: Depression
timeFrame: 2, 4 and 6 months after enrollment
measure: Patient satisfaction with care
timeFrame: 2, 4 and 6 months after enrollment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Camilla Zimmermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.