Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer
2021年11月19日 更新者：Ryan Nipp、Massachusetts General Hospital
Pilot Study Of A Transdisciplinary Intervention Integrating Geriatric And Palliative Care With Oncology Care For Older Adults With Cancer
The purpose of this research study is to pilot test a transdisciplinary intervention that integrates both geriatrics and palliative care with routine oncology care for older adults with incurable cancer.
The investigators will explore their perceptions of the supportive care needs of older patients with cancer.
Using these data, the investigators will finalize the transdisciplinary intervention and perform a pilot, randomized trial of the transdisciplinary intervention versus usual care in patients age ≥65 with newly diagnosed, incurable cancer.
研究概览
详细说明
While evidence suggests that older adults with incurable cancer have unique geriatric and palliative care needs, models of care that are focused on these needs are lacking. The investigators propose to pilot test an intervention targeting the geriatric and palliative care needs of older adults with incurable cancer, referred to as a "transdisciplinary intervention."
The goals of the proposed study are: (1) conduct focus groups with clinicians (from oncology, geriatrics and palliative care) and interviews with patients to explore their perceptions of older patients' supportive care needs and finalize the transdisciplinary intervention; (2) to demonstrate the feasibility and acceptability of delivering the transdisciplinary intervention to older patients with incurable GI and lung cancers; and (3) to estimate the effect size of the transdisciplinary intervention for patient-reported outcomes (e.g., between-group differences from baseline to week 12 in quality of life, physical function, physical and psychological symptoms).
研究类型
介入性
注册 (实际的)
62
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 65 or older
- Diagnosed with incurable (defined as metastatic or receiving chemotherapy with palliative intent) esophageal, gastric, pancreas, hepatobiliary, colorectal, or lung cancer within the prior 8 weeks (including patients with prior diagnosis of cancer who developed incurable disease)
- Verbal fluency in English
- Planning to receive care at Massachusetts General Hospital (MGH)
Exclusion Criteria:
- Unwilling or unable to participate in the study
- Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
- No medical problems for geriatric clinician to address (e.g. comorbidities, polypharmacy, etc.)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Transdisciplinary Intervention
Patients randomized to the Transdisciplinary Intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool. -Investigators will test a two-visit Transdisciplinary Intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit. |
Patients randomized to the transdisciplinary intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool, completed prior to their visit.
We will test a two-visit transdisciplinary intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit.
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有源比较器：Usual Care
Participants receiving Usual Oncology Care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.
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Participants receiving usual oncology care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Perceptions of the necessary components of a transdisciplinary intervention integrating geriatrics and palliative care with oncology care for older patients with incurable GI and lung cancers.
大体时间：2 years
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We will use qualitative assessment methods to characterize the sample and explore participant perceptions of the supportive care needs of older patients with cancer.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rates of study enrollment (proportion of eligible patients who enroll in the study).
大体时间：18 Months
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To demonstrate feasibility, investigators will calculate rates of study enrollment (proportion of eligible patients who enroll in the study).
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18 Months
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Rates of study completion (the proportion of participants who complete both study visits).
大体时间：18 Months
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To demonstrate feasibility, investigators will calculate rates of study completion (the proportion of participants who complete both study visits).
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18 Months
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Mean change in Quality of Life (measured with the Functional Assessment of Cancer Therapy (FACT) - General) scores between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in QOL scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in symptom scores (measured continuously with the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in symptom scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in depression scores (measured continuously with the Geriatric Depression Scale (GDS)) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in depression scores between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Rates of post-intervention moderate/severe symptoms (measured as presence or absence of moderate/severe symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r)) between treatment groups.
大体时间：From Baseline to week 12
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We will compare rates of post-intervention moderate/severe symptoms (defined as ESAS scores ≥4) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Rates of post-intervention depression symptoms (measured as presence or absence of depression symptoms using the Geriatric Depression Scale (GDS)) between treatment groups.
大体时间：From Baseline to week 12
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We will compare rates of post-intervention depression symptoms (defined as GDS scores > 5) between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in activities of daily living (measured continuously using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in instrumental activities of daily living between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in illness perceptions (measured continuously using the Brief Illness Perceptions Questionnaire (BIPQ)) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in illness perceptions between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Mean change in self-efficacy (measured continuously using the Perceived Efficacy in Patient-Physician Interactions (PEPPI)) between treatment groups from baseline to week 12.
大体时间：From Baseline to week 12
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We will compare mean change in self-efficacy between treatment groups from baseline to week 12 using t-tests and multiple linear regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Rates of post-intervention deficits in activities of daily living (measured as presence or absence of deficits in activities of daily living using a subscale of the Medical Outcomes Study (MOS) Physical Health) between treatment groups.
大体时间：From Baseline to week 12
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We will compare rates of post-intervention deficits in activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Rates of post-intervention deficits in instrumental activities of daily living (subscale of the Multidimensional Functional Assessment Questionnaire from the Older American Resources and Services (OARS)) between treatment groups.
大体时间：From Baseline to week 12
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We will compare rates of post-intervention deficits in instrumental activities of daily living between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
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From Baseline to week 12
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Rates of hospice enrollment prior to death (measured as rates of hospice enrollment prior to death) between treatment groups.
大体时间：From Baseline until Death, assessed up to 5 years
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We will compare rates of hospice enrollment prior to death between treatment groups using Fisher's exact test and multiple logistic regression, adjusted for potential confounders, such as age and gender.
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From Baseline until Death, assessed up to 5 years
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Acceptability of the Transdisciplinary Intervention To Older Patients With Incurable GI And Lung Cancers.
大体时间：18 Months
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Investigators will evaluate acceptability using exit assessment data. Participants will rate their satisfaction with the structure, timing and content of the intervention, using Likert-type scale responses. Investigators will calculate individual item response frequencies using descriptive statistics to summarize acceptability of different intervention components. |
18 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ryan Nipp, MD、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年10月1日
初级完成 (实际的)
2018年10月1日
研究完成 (实际的)
2018年12月20日
研究注册日期
首次提交
2016年7月30日
首先提交符合 QC 标准的
2016年8月13日
首次发布 (估计)
2016年8月16日
研究记录更新
最后更新发布 (实际的)
2021年11月23日
上次提交的符合 QC 标准的更新
2021年11月19日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.