Descriptors and Predictors of Burden and Information Needs
2020年7月15日 更新者：Saengrawee Thanthong、Chulabhorn Cancer Center
Descriptors and Predictors of Burden and Information Needs on Symptom Self-management in Thai Patients With Lung Cancer and Their Family Caregivers During Palliative Radiotherapy
the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(RT) for lung cancer.
Repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers.
In addition, I will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers.
These predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.
研究概览
详细说明
Eligible patients will be invited to take part in the study via a patient information sheet. They will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. We will give patients and caregivers 24 hours to decide whether they want to take part or not. If they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. These four time points will be the following:
- before first fraction of RT
- 1st week of RT (1st-5th faction)
- 2nd week of RT (6th-10th fraction)
- 1 month after the last fraction of RT The principal researcher, i.e. Saengrawee Thanthong, will endeavour to collect questionnaires in the hospital. If participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.
研究类型
观察性的
注册 (实际的)
112
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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Bangkok、泰国、10210
- Chulabhorn 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
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
取样方法
概率样本
研究人群
People diagnosed with advanced lung cancer and scheduled to receive palliative RT and their carer will be invited to participate between 1st september 2019 and 29 Febuary 2020.
描述
Inclusion Criteria:• Inclusion criteria for patients:
- Histological diagnosis of Lung cancer with stage III-IV(TNM)
- Age: 18 years or over
- Planning for palliative RT
Scheduled to receive up to 10 fractions of palliative radiotherapy (Stevens, Macbeth, Toy, Coles, & Lester, 2015)
• Exclusion criteria for patients:
- Non-English, Non-Thai speaking
- Diagnosis of severe cognitive or mental illness that affects communication
Patients' family caregivers will also be invited to participate as per below:
Inclusion criteria for caregivers:
- Family member of the care recipient can be spouse, child, parent, friend etc.
- Age: 18 years or over
- Only one family member if the patient presents with more than one.
- Same person in every time point
Exclusion criteria for caregivers:
- Non-English, Non-Thai speaking
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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patients
People diagnosed with advanced lung cancer and scheduled to receive palliative RT will be invited to participate between 1st July 2019 and 31st January 2020.
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Two questionnaires in patients and another two questionnaires in carer.
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care giver
Patients' family caregivers will also be invited to participate
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Two questionnaires in patients and another two questionnaires in carer.
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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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Changes of symptom experiences
大体时间：These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.
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Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)
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These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.
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Changes of information need
大体时间：These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.
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information need on symptom self-management at home measure by The Supportive Care Needs Survey - Patient version (SCNS) (Bonevski et al., 2000& McElduf et al., 2004) and Partners and Caregivers version (SCNS-P&C) - Information needs subscale.
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These four time points will be the following: before first fraction of RT, 1st week of RT (1st-5th faction), 2nd week of RT (6th-10th fraction) and 1 month after the last fraction of RT.
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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 (实际的)
2019年10月1日
初级完成 (实际的)
2020年2月29日
研究完成 (实际的)
2020年2月29日
研究注册日期
首次提交
2019年8月2日
首先提交符合 QC 标准的
2019年8月23日
首次发布 (实际的)
2019年8月28日
研究记录更新
最后更新发布 (实际的)
2020年7月17日
上次提交的符合 QC 标准的更新
2020年7月15日
最后验证
2020年7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.
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