Intervention Tool STEP Displays Feasibility in Identifying Patients Benefitting From Early Palliative Care

Researchers determined it feasible to distinguish between patients with advanced cancer who remain stable without and with early palliative care by utilizing the novel intervention tool Symptom screening with Targeted Early Palliative care.

Utilizing the novel intervention tool Symptom screening with Targeted Early Palliative care (STEP), researchers determined it was feasible to distinguish between patients with advanced cancer who remain stable without early palliative care (EPC) and those who will benefit from targeted EPC, according to research published in the Official Journal of the National Comprehensive Cancer Network.1

Researchers came to this conclusion over the course of a single-arm, phase 2 trial (NCT04044040) that looked at the feasibility of the STEP intervention, to identify patients with worse quality of life (QoL)outcomes and see whether screen-positive patients that received EPC had better outcomes over time compared to those who did not. What researchers found was that among the 116 patients enrolled in the trial, 77% (n = 89) completed STEP screenings for most of their visits (70% or more).

Among these patients, 70 were determined to be screen-positive and in need of EPC, but 39 patients (56%) received their EPC during the 6-month study, and 4 (6%) received it after the study. Screen-positive patients had worse QoL, depression, and symptom control compared to screen-negative patients (P < .0001) at baseline, with screen-negative patients remaining stable overtime. However, mood and symptom control improved overtime for screen-positive patients for patients who accepted and received EPC, whereas these outcomes then worsened for patients who did not receive EPC (P < .01), with no difference in QoL or satisfaction with care.

According to the researchers, these trends remained significant when adjusting for patient characteristics such as age, sex, tumor site, and baseline Edmonton Symptom Assessment System-revised(ESAS-r) distress score.

“Those who never screened positive had better [patient reported outcomes] at baseline than those who screened positive, and they maintained these favorable outcomes over time,” the researchers wrote. “Among those [patients] who screened positive, those who received EPC had improved mood and improved symptom control over time, compared with those who did not receive EPC. These results are important in the planning of future trials and for clinical practice for patients with advanced cancer.”

The median number of triggering symptoms in the patients who were screen-positive was 1 (range, 1-7) for the 32 patients who attended their offered EPC visit, and 2 (range, 1-9) symptoms for the 38 who did not attend. According to the researchers, the mean severity of all observed triggering symptoms was 6.20 (SD, 1.87) for the patients who had an EPC visit, and 5.91 (SD, 1.52) for those who did not (P = .48). The most common of the triggering symptoms among patients was anxiety (47%), pain (40%), and depression (36%).

Patient attendance for EPC visits were highest for pain as a triggering symptom (57%) and lowest for appetite (29%) as a triggering symptom. Other triggering symptoms included drowsiness, dyspnea, and well-being as defined by the 9 common cancer symptoms in the ESAS-r.

The study was conducted at the Princess Margaret Cancer Centre, a comprehensive cancer center that is part of the University Health Networkin Toronto, Ontario, Canada. The center has a palliative care program that consists of both outpatient and inpatient services, along with an acute palliative care unit. Routine symptom screening wasinitiated in 2006 in Ontario and has become mandatory across its 14 cancer centers since 2008.2,3 

This allowed for the researchers to have the most robust options for their novel intervention program, and patients with lung, gastrointestinal, genitourinary, breast, and gynecologic cancer were recruited for the study. Eligible patients consisted of adults aged 18 years or older, with advanced cancer defined as stage IV or hormone-refractory for patients with breast or prostate cancer. Patients with stage III lung and pancreatic cancer were also included.

The STEP program was a screening program given at every outpatient visit using ESAS-r, with targeted EPC referral given according to an algorithm based on the severity of the symptom. Severity of the symptom was then rated on an 11-point scale with 0 defined as “absent or best,” and 10 as worst. Moderate to severe scores for 1 or more symptoms triggered an email to a palliative care triage nurse who then contacted the screen positive patients to furtherassess the patient’s symptoms. The triage nurse then explained the importance of EPC and offered an EPC visit or palliative care clinic appointment.

The triage nurse informed the patient’s oncologist of each call and outcome, keeping a log of information as to whether the patient had a visit or not. Reasons for declining the visit were recorded and the patient was kept in the system to trigger future emails. Patients who accepted were assessed within 2 weeks and follow-up depending on their symptoms at 4 and 6 months. If needed, patients could be recommended for 24/7 care and had an available hotline for the triage nurse.

“This phase II trial showed that patients with mild or no symptoms may not require EPC intervention to maintain good QoL. STEP identified those who were most likely to benefit from EPC and indicated improvements in those who attended the targeted EPC visit compared with those who declined EPC,” the researchers concluded.“Based on these findings, a multicenter randomized trial of STEP versus standard palliative care in patients with advanced cancer is underway.”

1. Zimmermann C, Pope A, Hannon B, et al. Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer. J Natl ComprCancNetw. 2021 Sep 7;20(4):361-370.e3. doi: 10.6004/jnccn.2020.7803
2.Dudgeon D, King S, Howell D, et al. Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening. Psychooncology. 2012 Apr;21(4):357-64. doi: 10.1002/pon.1918
3.Barbera L, Moody L. A Decade in Review: Cancer Care Ontario's Approach to Symptom Assessment and Management. Med Care. 2019 May;57 Suppl 5 Suppl 1:S80-S84. doi: 10.1097/MLR.0000000000001084
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