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Pretransplant Evaluation by Supportive Care Team for Patients Undergoing HCT for Hematological Malignancies

2018年2月22日 更新者:Wendy Peltier、Medical College of Wisconsin

Feasibility of Implementing Pretransplant Evaluation by the Supportive Care Team for Patients Undergoing Hematopoietic Cell Transplantation for Hematological Malignancies

This is a feasibility study of pre-transplant involvement of a palliative care provider in the setting of HCT. Although this is primarily a feasibility pilot, the investigators will explore how patients are affected by the palliative care meetings as well as test data collection mechanisms that would be used in a future randomized clinical trial.

The investigators hypothesis is that patients will be amenable to pre-transplant involvement of the palliative care team and might welcome the chance to discuss palliative care issues separate from the primary team. Palliative care providers also have special training and experience in conducting these interactions and expertise in supportive care practices. They will be available should a patient's condition become life- threatening. This study is therefore designed primarily to evaluate the level of comfort / distress of patients when a palliative care consultation and follow-up are integrated into their care.

研究概览

详细说明

After the patient provides written informed consent, they will be given a survey to collect baseline data. Because input may be solicited from the caregiver, consent will also be obtained from a caregiver. Participation is optional for the caregiver and a caregiver is not required for the participant to be in the study. If the caregiver does not consent to participate in the study, his/her input during meetings will not be documented in the research record. "Caregiver" may vary from patient to patient, but for the purposes of this study would be an individual who listens to the interview and responds to questions related to the patient's psychosocial history, goals and values. This information gathered from the caregiver supports the details of the consult but does not stand alone. The caregiver does not complete an evaluation of the interview but can reach out to study coordinators if the interview causes any distress.The first consultation will be scheduled with a palliative care provider, but will take place after the standard of care meeting with the social worker so that the palliative care clinician can read the social work note and not have to review the same information. Within one to seven days after the meeting with palliative care, patients will be asked to complete a 15 minute interview to provide feedback on the meeting. A brief questionnaire will also be administered to the palliative care provider who conducted the consultation, ideally immediately after the meeting. Patients will meet at least monthly with the palliative care provider while they remain at the transplant center. Patients will complete additional self-assessments at day 60+/- 7 days and 90+/- 7 days after their transplants. These surveys may be completed by mail if the patient has been discharged from the center. The medical records of participants will be reviewed to pilot items collecting data about references to the palliative care consultation and use of ACP within the first 100 days after HCT. Costs for participants will be retrieved from the inpatient and outpatient accounting systems for the first 100 days after HCT. Participants may decline to participate in any part of the study or discontinue participation at any time.

研究类型

介入性

注册 (实际的)

7

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

    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Froedtert Hospital and the Medical College of Wisconsin

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

18年 及以上 (成人、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:

  • Written informed consent
  • English as primary language
  • Planned allogeneic stem cell transplantation
  • At least 18 years of age

Exclusion Criteria:

  • Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team.
  • First transplant of a planned tandem procedure (the second transplant is eligible)

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Palliative Care Support
Palliative care meetings will address the following issues: 1) values and meaning of life 2) greatest hopes and fears 3) communication preferences 4) proxy readiness to make decisions, and patient preferences, if the patient were to become seriously ill, and 5) symptom management strategies.
Palliative care meetings Quality of Life Assessments

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
Study participation rates
大体时间:1 year
The proportion of patients who consent to enroll in the study will be computed based on the number approached. Reasons for non-participation will be summarized.
1 year

次要结果测量

结果测量
措施说明
大体时间
Completion time for palliative care consultation
大体时间:up to 100 days
up to 100 days
Level of comfort / distress attributed to individual parts of the consultation
大体时间:Within 1-7 days after the initial consultation
The post-consultation scores measuring level of comfort or distress per topic in the palliative care consultation will be summarized per item.
Within 1-7 days after the initial consultation
Completeness of follow-up data collection
大体时间:1 year after the date last patient is enrolled
Completeness is defined by the proportion of instrument scores that can be calculated per given time point. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.
1 year after the date last patient is enrolled

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:Wendy Peltier, MD、Medical College of Wisconsin

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

2015年2月1日

初级完成 (实际的)

2017年10月1日

研究完成 (实际的)

2017年10月1日

研究注册日期

首次提交

2014年10月18日

首先提交符合 QC 标准的

2014年12月16日

首次发布 (估计)

2014年12月22日

研究记录更新

最后更新发布 (实际的)

2018年2月23日

上次提交的符合 QC 标准的更新

2018年2月22日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

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.

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