NCT05270395已完成不适用
Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice Palliative Care Into Advanced Stage Lung Cancer Treatment
Laurie McLouth2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年7月28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
- 75
- 试验地点
- 2
- 主要终点
- Feasibility of Enrollment
研究概览
简要总结
The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.
详细描述
In this study, 60 advanced stage lung cancer patients will be randomized to mPal's patient-level component or usual care. Oncology providers will receive the mPal intervention. mPal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; NHPC) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for NHPC discussions when patients are in clinic to see their oncology providers; and 3) provider education about NHPC.
This study will examine the feasibility and acceptability of mPal and gather preliminary data on potential outcomes for a future effectiveness trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •new or recurrent AJCC stage IIIb-IV non-small cell lung cancer or extensive stage small cell lung cancer
- •ECOG performance status 0-3/Karnofsky 40-100
- •at least three weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-immunotherapy)
排除标准
- •unstable brain metastases
- •Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate
- •Receiving palliative care
- •Unable to speak and read English
结局指标
主要结局
Feasibility of Enrollment
时间窗: up to 6 months
Enrollment feasibility is defined as the number of eligible and approached patients who agree to participate
次要结局
- Feasibility of Retention(up to 2-months post-intervention)
- Acceptability of Intervention(up to 2 weeks post-intervention viewing)
- Change in Palliative Care Attitudes(Baseline, up to 2-months post intervention)
- Feasibility of Intervention(up to 2 weeks post-intervention viewing)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 1: How Would You Describe Your Level of Knowledge About Palliative Care?(Baseline and at 1-month follow-up)
- Patient Palliative Care Referrals(up to 3-months post-intervention)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 3: Offer Social and Emotional Support(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 5: Give Patients More Time at the End of Life(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 6: Accepting Palliative Care Means Giving up(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 7: It is a Doctor's Obligation to Inform All Patients With Cancer About the Option of Palliative Care(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 8: If You Accept Palliative Care, You Must Stop Other Treatments(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 9: Palliative Care is the Same as Hospice Care(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 2: Help Friends and Family to Cope With a Patient's Illness(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 4: Manage Pain and Other Physical Symptoms(Baseline and at 1-month follow-up)
- Change in Palliative Care Knowledge - Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire (HINTS), Item 10: When I Think of "Palliative Care," I Automatically Think of Death(Baseline and at 1-month follow-up)
研究者
Laurie McLouth
Assistant Professor
University of Kentucky
研究点 (2)
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