Descriptors and Predictors of Burden and Information Needs
2020년 7월 15일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
112
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bangkok, 태국, 10210
- Chulabhorn Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes of symptom experiences
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 10월 1일
기본 완료 (실제)
2020년 2월 29일
연구 완료 (실제)
2020년 2월 29일
연구 등록 날짜
최초 제출
2019년 8월 2일
QC 기준을 충족하는 최초 제출
2019년 8월 23일
처음 게시됨 (실제)
2019년 8월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 7월 15일
마지막으로 확인됨
2020년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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