Symptom Screening With Targeted Early Palliative Care (STEP2) Versus Routine Early Palliative Care in Patients With Advanced Cancer: A Randomized Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
研究概览
简要总结
Palliative care aims to improve quality of life for people with advanced illness, and early palliative care (EPC) has been shown to benefit patients with late-stage cancer. However, specialist teams do not have the capacity to see all patients; on the other hand, many who would benefit are not referred. To address this, the investigators created STEP2, a system that combines online symptom screening with targeted palliative referrals. Eligible patients with advanced cancer are randomly assigned to routine EPC-where all receive a referral-or to STEP2, where referrals occur only if moderate-to-severe symptoms are reported. Patients complete questionnaires on quality of life, satisfaction, symptoms, depression, and goals of care at baseline, 16 weeks, and 24 weeks. The study will assess whether STEP2 is as good as receiving routine EPC by comparing the results of the questionnaires in each group.
详细描述
Palliative care (PC) is provided by a team of specialists focused on improving quality of life (QOL) for patients with advanced illness by offering symptom management and additional support for the patient and their caregivers. Studies have shown that early integration of PC (EPC) in an outpatient setting for patients with advanced cancer improved their QOL and overall satisfaction with care. Despite research proving the benefits of EPC, patients with the greatest need are not often referred to outpatient palliative care clinics due to resource restraints. Routine screening for symptom burden is recommended in clinical practice guidelines and can identify patients with the greatest need for EPC. In Ontario, Canada symptom screening is performed before every outpatient visit at all cancer centers. However, there has been no system that combines symptom screening with targeted EPC.
The investigators developed a system that combines routine symptom screening with targeted early palliative care (STEP); the latest version, STEP2, includes both in-person and virtual care, to reflect current practice. Patients are eligible to participate if they have advanced cancer, a prognosis of 6-36 months, good functional status, and can complete the online symptom screening. Enrolled patients will be randomly assigned to either the routine EPC or STEP2 groups. The STEP2 group will continue to complete routine symptom screening before their oncology visits and will only receive an outpatient palliative care clinic referral if they record a moderate-to-severe symptom score. The EPC group will automatically receive an outpatient palliative care clinic referral regardless of symptom scores. All patients will complete questionnaires evaluating QOL, satisfaction with care, symptom control, depression, and goals of care outcomes at recruitment, 16 weeks, and 24 weeks.
The investigators will review the measures for the STEP2 and EPC groups to determine whether STEP2 is as good as receiving routine EPC. Results from this study could provide access to palliative care for those patients who most need it, thereby improving their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Stage IV cancer (endocrine-resistant ER+ breast and castration-resistant prostate cancer; stage 3 included for lung or pancreatic cancer)
- •Oncologist-estimated Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Oncologist-estimated prognosis of 6-36 months
- •Willingness to complete virtual ESAS-r+ screening before each appointment
排除标准
- •Insufficient English literacy to complete study questionnaires
- •Severe cognitive deficit, as per treating oncologist
- •Receiving specialized palliative care
研究组 & 干预措施
STEP2
Receives a referral only if they report moderate-to-severe symptoms.
干预措施: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2) (Behavioral)
Routine EPC
Automatically receives early palliative care referral.
干预措施: Early Palliative Care (EPC) (Behavioral)
结局指标
主要结局
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
时间窗: 16 weeks
A 39-item measure consisting of the 27-item FACT-G subscale and the 12-item FACIT-Sp-12 subscale. Scores range from 0-4 per item with higher scores indicating worse quality of life.
次要结局
- Mean Number of Outpatient Palliative Care Visits(24 weeks)
- Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)(24 weeks)
- Family Satisfaction with Care - Patient Version (FAMCARE-P16)(16 and 24 weeks)
研究者
Camilla Zimmermann
Prinicipal Investigator
University Health Network, Toronto