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临床试验/NCT04069494
NCT04069494已完成不适用

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

Chulabhorn Cancer Center1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年10月1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
112
试验地点
1
主要终点
Changes of symptom experiences

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Changes of symptom experiences

时间窗: 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.

Measure by the Thai version of modified version of the Memorial Symptom Assessment Scale (MSAS)

Changes of information need

时间窗: 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.

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.

次要结局

未报告次要终点

研究者

发起方
Chulabhorn Cancer Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Saengrawee Thanthong

Principal Investigator

Chulabhorn Cancer Center

研究点 (1)

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