Pilot Study of the SPaRK (Supportive and Palliative Care Review Kit) Model of Care for Advanced Cancer Patients Who Have an Unplanned Admission to Singapore General Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 865
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
Advanced cancer patients have a poor quality of life and a high rate of unplanned hospital admissions. Palliative care has been shown to improve patient outcomes such as quality of life and symptom burden. Our long-term aim is to study the effect of Supportive and Palliative Care Review Kit (SPaRK) - a novel model of early palliative care in the acute hospital inpatient setting. To this end, we propose a pilot study that will provide the necessary information for the planning of a subsequent larger scale Phase III trial of SPaRK.
The specific aims of this pilot study are: 1) to estimate the recruitment rate and ability of advanced cancer patients to complete the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which measures health-related quality of life (QOL) in the four domains of physical well-being, social/family well-being, emotional well-being, and functional well-being, 2) to obtain a tentative estimate of the effect size of the SPaRK model of care on change in patient QOL over 6 days, 3) to explore the responsiveness to change of FACT-G over 3 days and 4) to explore views of healthcare professionals and stakeholders on SPaRK as a model of integrated palliative care and oncology care service delivery.
In the short term, the results from this study will be used to plan a larger scale Phase III study of SPaRK. In the long term, a resource-efficient and effective model of care needs to be developed for the aging population and rising palliative care needs of patients. If successful, this pilot study will lead on to the testing of SPaRK, which does not rely wholly on specialist palliative care manpower, but involves both specialists and non-specialists working together to provide palliative care, and hence can be feasibly scaled up across institutions and extended to non-cancer patients.
详细描述
Specific Aims ==========
This is a pilot study of the Supportive and Palliative care Review Kit (SPaRK) model of care, which is integrated palliative care and oncology care for advanced cancer patients, and will be focused on improving outcomes in lung cancer patients in the acute hospital inpatient setting. The current usual care will be provided in the first 3-month period from 1 October to 31 December 2015, and the novel SPaRK model of care will be piloted in the latter 3-month period from 1 January to 31 March 2016. The overall aim of this pilot study is to facilitate the planning of an upcoming phase III trial.
Specific aim 1: To estimate the recruitment rate and data completion rate of the FACT-G instrument We will estimate the recruitment rate and data completion rate for FACT-G, which will demonstrate the feasibility and help in the planning of the future Phase III trial. The measurement properties of FACT-G will be detailed later in the 'Methods' section of this proposal. The FACT-G questionnaire will be administered at up to four time points - day 1, 4 and 7 of hospital admission and day of discharge.
Specific aim 2: To obtain tentative estimate the effect size of SPaRK on change in FACT-G from day 1 to day 7 of hospital admission The control group will be hospital admissions that are managed under the current model of care. The intervention group will be hospital admissions that are managed under the new SPaRK model of care. We hypothesize that the SPaRK model of care will result in a greater improvement in FACT-G score from day 1 to day 7 of hospital admission.
Specific aim 3: To explore the responsiveness to change of FACT-G from day 1 to day 4 of hospital admission Within the three-day period from day 1 to day 4 of hospital admission, we expect the acute problems that prompted the admission to be addressed. The patient's 'phase of illness' will be recorded by the primary medical oncology physician on day 1 and day 4 as part of the study protocol. For patients who change from an 'unstable phase' on day 1 to 'stable phase' on day 4, we will estimate the responsiveness to change of FACT-G score in terms of association with this change. Even though FACT-G uses a recall period of seven days, we hypothesize that FACT-G score will nonetheless increase among patients who change from an 'unstable phase' to 'stable phase' over the shorter time period of three days from day 1 to day 4 of hospital admission while there is no change in FACT-G score among patients who remained in the 'unstable phase. This would be useful for measuring outcomes in patients who are discharged before day 7 of hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has an unplanned admission to SGH under the care of the inpatient DMO Lung team
- •Has a cancer diagnosis of stage 4 solid tumor
- •Has capacity to give written informed consent to participate in the study (for patients who complete the patient questionnaires)
排除标准
- •Unable to complete self-administration of the FACT-G questionnaire
研究组 & 干预措施
Control
Usual care: Oncology team refers patients to palliative care team if deemed appropriate
Intervention
Integrated oncology care and palliative care
干预措施: Integrated palliative oncology care (Other)
结局指标
主要结局
Quality of life
时间窗: 6 days
Functional Assessment of Cancer Therapy - General (FACT-G)
次要结局
未报告次要终点
