Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency of patients' ED visits and hospitalizations
研究概览
简要总结
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
详细描述
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled.
This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted.
In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Newly diagnosed with a solid tumor-type cancer that is considered either advanced and unresectable or metastatic
排除标准
- •Non-English speaking
- •Age < 18
结局指标
主要结局
Frequency of patients' ED visits and hospitalizations
时间窗: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
次要结局
- Caregiver burden(Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months)
- Caregiver satisfaction(Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months)
- Patient satisfaction(Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months)
- Patient quality of life(Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months)
- Patient symptoms(Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months)