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临床试验/NCT02307539
NCT02307539已完成不适用

Feasibility of an Interdisciplinary Palliative Care Planning Intervention in Pancreatic Cancer

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Completion of intervention

研究概览

简要总结

This pilot clinical trial studies a palliative care program in improving the quality of life of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients who have a serious or life-threatening disease, and focuses on managing disease symptoms, side effects of treatment or the disease, and improving patient quality of life. Studying a palliative care program used for other types of cancer may help doctors learn whether it can improve the quality of life of patients with pancreatic cancer.

详细描述

PRIMARY OBJECTIVES:

I. To pilot-test an interdisciplinary Palliative Care Planning Intervention (PCPI) in pancreatic cancer. Specifically, to describe patients' satisfaction with the timing, content, and delivery of the PCPI intervention.

SECONDARY OBJECTIVES:

I. To pilot-test all selected measures for the study, including measures for healthcare resource utilization, overall cost, and patient/family out of pocket expenses.

II. The long-term objective of this pilot study is to conduct a larger PCPI intervention study for pancreatic cancer patients and evaluate its impact on quality of life (QOL), symptom intensity, healthcare resource utilization, and healthcare costs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Pathologically confirmed, new diagnosis of borderline resectable, locally advanced resectable/unresectable, or metastatic pancreatic cancer
  • Patients who are scheduled to receive treatments (neoadjuvant therapy, surgery, adjuvant therapy, or palliative chemotherapy) at City of Hope (COH)
  • All subjects must have the ability to understand and the willingness to provide informed consent

排除标准

  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

结局指标

主要结局

Completion of intervention

时间窗: Up to 2 months

Descriptive statistics will be provided.

Reasons for refusal to participate

时间窗: Up to 2 months

Descriptive statistics will be provided.

Attendance at two educational sessions

时间窗: Up to 2 months

Descriptive statistics will be provided.

Patient satisfaction with timing, content, and delivery of PCPI

时间窗: Up to 2 months

Presented through summary statistics of data from the patient satisfaction tool.

Qualitative interview data

时间窗: Up to 2 months

Each interview transcript will be initially reviewed to provide a glimpse of potential domains and targets. Content analysis will be conducted on the transcribed qualitative data. Transcripts will be assigned codes. Content analysis occurring through coding consisting of line-by-line analysis with themes identified will be initiated. The research team will independently analyze selected segments of the data to verify themes. Coding will be checked and validated by the principal investigator and research team.

Reasons for failure to complete study

时间窗: Up to 2 months

Descriptive statistics will be provided.

次要结局

  • Healthcare resource utilization, as measured by the Report of Healthcare Services Form(Up to 2 months)
  • Overall cost, as measured by the Finances and Out of Pocket Costs Tool(Up to 2 months)
  • Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool(Up to 2 months)

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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