Quality of End-of-Life Care for Children With Cancer: A COG Groupwide Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,425
- 试验地点
- 28
- 主要终点
- Quality of end of life (EOL) care
研究概览
简要总结
This study examines the role of access to care, patient/family interactions with the healthcare system, and stress in explaining variations in quality of end-of-life care. The data collected from this study may help researchers develop a model for identifying patients at risk of low-quality end-of-life care as well as recommendations for potential future interventions.
详细描述
PRIMARY OBJECTIVE:
I. Examine the role of access to care, patient/family healthcare interactions, and stress in variation in quality of end-of-life (EOL) care.
OUTLINE: This is an observational study.
PART 1: The medical records of deceased patients are reviewed on study.
PART 2: Bereaved parents complete a survey and may participate in an interview on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Index Child (COG Registered Patient):
- •Must be deceased
- •< 18 years old at time of death
- •Diagnosed with any oncologic condition
- •History of enrollment on Stratum 1 of APEC14B1, Project:EveryChild
- •Note: history of treatment on a COG therapeutic trial is not required
- •Resided in the United States, including Puerto Rico, as evidenced by most recent address, at the time of death
- •Bereaved Parent(s):
- •Must be a parent, legal guardian, or caregiver (biological or non-biological) of an eligible Index Child enrolled on APEC14B1 with current Consent to Future Contact (e.g., from the APEC14B1 Part B Consent)
- •Self-reported confirmation of familiarity with the care received by the Index Child in the last month of their life
- •Bereaved parent must understand English or Spanish (written and/or spoken)
- •Must be a parent/guardian/key contact from the Index Child's APEC14B1 Future Contact study record or must be referred by one of the APEC14B1 contacts
- •Bereaved parent must be >= 18 years old at the time of ALTE24C1 study enrollment
- •Regulatory Requirements:
- •Bereaved parent must provide verbal or implied informed consent
- •For all participants, all institutional, FDA, and NCI requirements for human studies must be met
排除标准
- 未提供
研究组 & 干预措施
Observational part 1
The medical records of deceased patients are reviewed on study.
干预措施: Non-Interventional Study (Other)
Observational part 2
Bereaved parents complete a survey and may participate in an interview on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Quality of end of life (EOL) care
时间窗: Up to study completion, an average of 4 years
Is a composite measure evaluated as the percent of applicable measures with high-quality care for each patient. For each child, will calculate the percent of measures applicable to that patient for which they met the criteria for high-quality care. Of note, not all measures will apply to every patient (e.g., assessment of sibling support will only apply to those with siblings). EOL quality will be treated as a continuous variable and will be modeled using linear mixed effects models with COG site included as a random effect. Models will be adjusted for key demographic (child: death age, race, ethnicity, insurance, biologic sex; parent: age, race, ethnicity, relationship to child, biologic sex) and clinical factors (cancer diagnosis, time from diagnosis to death, relapse status, clinical trial enrollment, cause of death, palliative care team at primary treatment site).
Quality of end of life (EOL) care
时间窗: 3 months to 2 years after the child's death
Is a composite measure evaluated as the percent of applicable measures with high-quality care for each patient. For each child, will calculate the percent of measures applicable to that patient for which they met the criteria for high-quality care. Of note, not all measures will apply to every patient (e.g., assessment of sibling support will only apply to those with siblings). EOL quality will be treated as a continuous variable.
次要结局
未报告次要终点