Effectiveness and Implementation of 'Supportive and Palliative cAre Review Kit in Locations Everywhere' (SPARKLE-2) - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
研究概览
简要总结
Advanced cancer patients often experience significant physical and emotional symptoms, which can lead to frequent hospital visits and reduced quality of life. Although palliative care can help manage these symptoms and improve well-being, it is often introduced too late.
A proactive symptom monitoring model, SPARKLE-2 aims to identify patients who need palliative care earlier by regularly checking their symptoms using a simple questionnaire. Patients with concerned symptoms will receive timely support from the palliative care team, with the goal of improving their quality of life, reducing unnecessary hospital admissions, and helping more patients receive care in the community rather than in hospital. In the earlier SPARKLE-1 study, it showed the improvement of patients' physical wellbeing. SPARKLE-2 seeks to test the effectiveness among advanced cancer patients with unplanned hospital visits while simultaneously collecting data on real-world implementation.
详细描述
To evaluate the effectiveness of SPARKLE-2, we will conduct randomized controlled trial comparing clinical outcomes at 3 months between patients receiving usual care and intervention. For longer-term impact of palliative care, we will also measure patient outcomes at 6, 9, and 12 months. To evaluate ways to improve implementation, the Consolidated Framework for Implementation Research (CFIR) will be used to systematically identify processes that influence implementation outcomes.
The specific aims and hypotheses of this mixed methods study are:
- Assess the effectiveness of SPARKLE-2 on health-related quality of life and healthcare utilization among patients with advanced cancer. We hypothesize that the SPARKLE-2 group compared to the usual care group participants will have better health-related quality of life, better health status, earlier palliative care utilisation, and less acute healthcare utilisation.
- Assess implementation processes of SPARKLE-2. We will assess acceptability, appropriateness, and feasibility through a structured survey among healthcare providers. Also, we will assess fidelity through completion rate of IPOS screening questionnaires and compliance with clinical response pathways. Implementation costs will be captured from the healthcare system's perspective prospectively using an activity-based costing approach.
- Assess contexts and mechanisms that bring about SPARKLE-2 outcomes. We will interview patients, caregivers and healthcare providers who were involved in SPARKLE-2 to explore their perspectives on factors, including facilitators and barriers, that bring about intervention effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for patients:
- •21 years old or older
- •Diagnosed of advanced cancer diagnosis, defined as metastatic or recurrent/ progressive Stage III/IV solid tumour
- •Has an unplanned hospital admission and expected to be discharged home
- •Able to speak English or Mandarin Chinese or Malay
- •Able to provide informed consent
- •Additional inclusion criteria for patient participants of semi-structured interviews are:
- •Enrolled in the SPARKLE-2 RCT, whether randomized to the SPARKLE intervention or usual care group and regardless of fidelity to trial procedures.
- •Inclusion criteria for caregivers:
- •21 years old or older
- •Self-endorsing or identified by an enrolled patient as a spouse/partner, relative or friend who knows them well and who provides support due to their cancer
- •Able to speak English or Mandarin Chinese or Malay
- •Able to provide informed consent
- •Inclusion criteria for healthcare providers:
- •21 years old or older
- •Healthcare professional who is involved in the clinical care of patients with advanced cancer for at least 50% of their work hours
- •Able to provide informed consent
- •Involved in the processes of the SPARKLE-2
排除标准
- •Exclusion criteria for patients:
- •Assessed by the treating physician as unable to complete study procedures
- •Unable to complete patient-reported outcome measures
- •Exclusion criteria for caregivers:
- •1. Unable to complete interviews
- •Exclusion criteria for healthcare providers:
- •Healthcare professionals that are not providing care for cancer patients.
- •Unable to complete interviews
结局指标
主要结局
Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)
时间窗: 12 weeks.
FACIT-Pal is a 46-item measure with a quality-of-life scale (4 domains: physical, emotional, social, and functional well-being) and a palliative care subscale. It has demonstrated internal consistency, reliability and validity for persons with advanced cancer. Quality of life is scored on a scale of 0 to 184, with higher scores indicating better outcomes.
次要结局
- Quality of life score measured using the Functional Assessment of Chronic Illness Therapy - Palliative (FACIT-Pal)(Every 12 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.)
- Palliative care concerns measured using the Integrated Palliative Care Outcomes Scale (IPOS)(Every 2 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.)
- Health states measured using the EuroQOL Group 5-Dimension Health-related Quality of Life Measurement (EQ-5D-5L)(Baseline, 12 weeks, 18 weeks, 27 weeks, and 48 weeks.)
- Acute healthcare utilization.(Baseline until death or end of the study, up to 48 weeks.)
- Inpatient healthcare utilization and the intervention's impact on inpatient healthcare utilization.(Baseline until death or end of the study, up to 48 weeks.)
- Healthcare expenditure associated with patient care and the economic impact on intervention.(Baseline until death or end of the study, up to 48 weeks.)