- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01399541
Recovery and Rehabilitation After Lung Cancer Surgery
The specific aims of this translational, interdisciplinary, multi-center, international research study with 300 Lung cancer patients are to:
Aim 1 Explore how the patients experience the transfer between different locations and between different levels of care at the same location and how they experienced coming home.
Aim 2 Explore lung cancer patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time.
Aim 3 Explore interaction between lung cancers patients' symptoms, symptom clusters, health related quality of life and social support.
연구 개요
상세 설명
Approximately 2500 patients are diagnosed with lung cancer annually i Norway, and approximately 400 of these undergo surgery. Many patients report that life after lung cancer surgery is difficult. After surgery, the patients are frequently transferred to a local hospital or to another level of care at the hospital where they were operated. The transfer is critical for patients' safety because communication failure is one of the most common causes of medical error.
Studies that have analyzed the quality of life of lung cancer patients after surgery reach different conclusions about the patients' Quality of life (QOL), some studies state that lung cancer patients are back to normal quality of life after 9 months, while others indicate that the patients still have reduced QOL two years after surgery. It is difficult to assess the reason for the differences in results as most of the studies used the same QOL questionnaire. Studies that have evaluated the social support that lung cancer patients receive indicate that lung cancer patients receive less support than other cancer patients.
Lung cancer patients have a wide range of physical problems (fatigue, dyspnea, coughing and pain) and psychological (depression) problems following surgery.
Based on findings from this literature review a need exist for improved postoperative follow-up of patients after surgery for lung cancer The proposed study will evaluate the social support, the levels of lung cancer stigma, symptoms and changes in this over time as well as evaluate patient experience with transfer in the immediate postoperative period.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Bergen, 노르웨이, 5021
- Haukeland Sykehus
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Oslo, 노르웨이, 0407
- Ullevaal University Hospital
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Oslo, 노르웨이, 0037
- Rikshospitalet, OUS
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Trondheim, 노르웨이, 7006
- St. Olavs Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients with lung cancer patients above the age of 18 that have been treated with surgery, who are able to speak and understand Norwegian,
Exclusion Criteria:
- and who suffer no cognitive impairment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Under and over 65 years
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Key measures that will be the focus of the study is Quality of life.
기간: 1 year with 5 measurement points
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Data will be collecetd using the self administered questionnaire: EORTC QLQ-C30 + LC13
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1 year with 5 measurement points
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The total burden of symptoms will be one key measures in this observational study.
기간: one year with 5 measuresments
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The self administered questionnaire: Memorial Assessment scale (MSAS) Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with 5 measuresments
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A key measure to measure fatigue will be used.
기간: one year with five measurements points
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The self administered questionnaire: Lee Fatigue Scale, LFS.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with five measurements points
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A key measures to measure sleep disturbances will be used.
기간: One year with five measurements points
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A questionnaire: General sleep disturbances scale (GSDS).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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A key measures will be used to evaluate social support
기간: One year with two measurements points
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The self administered questionnaire: Social Provision Scale.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with two measurements points
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A self administered questionnaire to measure Anxiety
기간: One year with five measurements points
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The self administered questionnaire: State and trait anxiety (STAI).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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A self administered questionnaire to measure pain
기간: one year with five measurements points
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The self administered questionnaire: Brief Pain Inventory.
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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one year with five measurements points
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Depression is a key measure
기간: One year with five measurements points
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The self administered questionnaire: Self-report depression scale (CES-D).
Key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study.
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One year with five measurements points
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One key measures that will be used to evaluate stigma related to having lung cancer in this observational study.
기간: 1 year with one measurements points
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Data will be collected using the self administered questionnaire: Cataldo Lung Cancer Stigma Scale (CLCSS)
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1 year with one measurements points
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tone Rustøen, PhD, Oslo University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .