The Science of the Art of Palliative Care Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms
研究概览
简要总结
This feasibility pilot study is designed to learn whether patients and their care partners (e.g., family members) are willing and able to complete two study visits at Dartmouth College while receiving cancer care at Dartmouth-Hitchcock Medical Center.
详细描述
A feasibility pilot open label, single-arm observational case series of 10 patients with metastatic gastrointestinal and lung cancer patients and 10 care partners. Participants will complete two study visits, separated by approximately 8-16 weeks of usual oncologic care with early integrated specialty palliative care. The palliative care physician will also be a study participant.
Primary Objective: To develop and refine study procedures which can be used in future research in order to further understanding of the mechanisms of action of specialty palliative. Expected products: manual of operating procedures and web-based data collection forms.
Secondary Objectives: To test the feasibility of conducting a mechanism-focused clinical trial of primary palliative care vs. specialty palliative care for advanced cancer patients and their care partners. Expected products: preliminary data demonstrating the feasibility of study procedures sufficient to prove this study design is possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •18 years or older
- •Patient: has received a diagnosis of advanced lung or gastrointestinal cancer within the last 24 weeks (note: advanced GI cancer will likely be pancreatic or colorectal)
- •Care partner: care partner of a patient who has received a diagnosis of metastatic lung or gastrointestinal cancer who has provided consent for study (either with our without functional MRI study visits)
- •Be able to understand study requirements and make an informed decision to participate
- •Be able to speak and read English
排除标准
- •Life expectancy of <8 weeks
- •Known brain metastases
- •Claustrophobia
- •Both patient and care partner refuse to participate in fMRI scan (ie., either patient or care partner must agree to an fMRI scan in order for either to participate)
- •Contraindications to MRI (e.g.: implanted or embedded metal/metal fragments. Metals in the body make the participant unable to undergo an MRI which makes them ineligible for study participation).
结局指标
主要结局
Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms
时间窗: 6 months
Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.
次要结局
- Acceptability as measured by willingness to recommend study participation to others.(6 months)
- Feasibility as measured by participant withdrawal rate(6 months)
- Tolerability as measured by rates of study procedure non-completion.(6 months)
- Feasibility as measured by participant interest(6 months)
- Feasibility as measured by enrollment number(6 months)
- Feasibility as measured by willingness to be randomized(6 months)
- Tolerability as measured by subjective units of distress scores (SUDS, 0-100)(6 months)
- Feasibility as measured by procedure completion rate(6 months)
- Acceptability as measured by response to questions of level of burden.(6 months)
研究者
Amber Barnato
Director, The Dartmouth Institute
Dartmouth-Hitchcock Medical Center