Aspects of Quality of Life During Adjuvant Oncological Treatment for Locally Advanced Lung Cancer Which Include Immune Checkpoint Inhibitor.
2026년 8월 30일 업데이트: Sofie Jakobsson, Göteborg University
Self-reported Health During Adjuvant Immunotherapy for Locally Advanced Lung Cancer - the ImmLungCare Project.
Current oncological treatment for patients with locally advanced lung cancer comprise adjuvant immunotherapy (immune checkpoint inhibitors-ICI) as an additional one-year treatment after chemoradiotherapy which increases overall survival and progression-free survival.
Patients with lung cancer have a high burden of distressful symptoms at diagnosis and during chemoradiotherapy.
Side-effects from immunotherapy differs, they are unspecific and may develop at any point during treatment.
However, it is not investigated thoroughly during adjuvant treatment in locally advanced lung cancer.
As new oncological treatments are being introduced, focus must be placed on patients quality of life and how patients endure treatment to be able to know how to best support patients during this treatment.
The knowledge gained from this project include how adjuvant immunotherapy treatment impacts health.
This knowledge is sparse due to the novelty of the treatment.
연구 개요
상태
모병
정황
연구 유형
관찰
등록 (추정된)
75
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sofie Jakobsson, Associated professor
- 전화번호: +46766182858
- 이메일: sofie.jakobsson@fhs.gu.se
연구 장소
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Gothenburg, 스웨덴, 405 30
- 모병
- Department of Oncology, Sahlgrenska University Hospital
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연락하다:
- Niklas Olofsson, PhD- student
- 이메일: niklas.olofsson@vgregion.se
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연락하다:
- Sofie Jakobsson, Ass. professor
- 이메일: sofie.jakobsson@fhs.gu.se
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
확률 샘플
연구 인구
Patients cared for at a specialized oncology centre in Västra Götaland, Sweden and at a regional hospital in Jönköping region in Sweden.
설명
Inclusion Criteria:
- Patients with locally advanced non-small lung cancer
- cared for at either one of two specialized oncology centres
- ≥ 18 years of age
- planned for concurrent chemoradiotherapy including ICI for 12 months
- performance status 0-2.
Exclusion Criteria:
- diseases or comorbidities that may have significant impact on the outcome variables
- limited understanding of the Swedish language preventing the possibility to give oral and written informed consent.
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 |
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Patients with locally advanced lung cancer cared for at two specialized oncology centres.
Inclusion criteria: locally advanced lung cancer, ≥ 18 years of age, planned for concurrent chemoradiotherapy including ICI for 12 months and performance status 0-2.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in aspects of Quality of life (totalscore and subscale scores) during oncological treatment measured with the questionnaire EORTC QLQ C30.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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Changes between baseline and 12 months after start of immunotherapy will be assessed with the European Organisation for Research and Treatment of Cancer Quality of life scale (EORTC QLQ-C30).
The 30 item instrument measure quality of life in patients with cancer.
Scores range from 0-100 where a higher score represents higher quality of life.
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From enrollment before oncological treatment up til 18 months after start of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in self-reported health during oncological treatment measured with EQ-VAS.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in general health will be assessed with EQ-VAS which is a visual analogue scale, measuring a persons overall health-related quality of life.
The scale ranges from 100 (the best health you can imagine) to 0 (the worst health you can imagine').
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in Quality of life specifically in patients with lung cancer during oncological treatment measured with the questionnaire EORTC QLQ - LC13.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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A lung cancer module to assess quality of life when having a lung cancer.
The European Organisation for Research and Treatment of Cancer Quality of life in lung cancer scale EORTC QLQ - LC13 comprise 13 items, scores range from 0-100 where a higher score represents better quality of life.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in well-being related to immune checkpoint modulators during oncological treatment measured with the questionnaire FACT-ICM.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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Functional Assessment of Cancer Therapy - Immune Checkpoint Modulator (FACT ICM) comprise 52 items (5 point Likert-type response alternatives between 0 not at all -4 very much).
Higher scores indicates better well-being.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in existensial health during oncological treatment measured with the questionnaire FACIT-Sp-12.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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Functional Assessment of Chronic Illness Therapy -Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) measures perceived existensial health with a 5 point Likert-type scale (0 not at all - 4 very much), higher score indicates better perceived existensial health.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Changes in health promoting factors during oncological treatment assessed with SOC-13.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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Sense of coherence scale (SOC-13) is a 13- item scale comprised of three components: Comprehensibility, Manageability and Meaningfulness.It aims to measure how persons cope with stressfull situations as for example cancer.
Scores 13-91 where higher scores indicate better coping strategies.
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From enrollment before oncological treatment up til 18 months after start of treatment
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in health promoting factors during oncological treatment assessed with SEMCD-4.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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A person's self-efficacy asessed with Self-Efficacy to Manage Chronic Disease (SEMCD) Scale.
With the SEMCD the patient rate confidence related to four tasks on a 1 to 10 scale (1 not at all confident" and 10 totally confident).
A higher score indicates better self-efficay.
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From enrollment before oncological treatment up til 18 months after start of treatment
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Perceived quality of care during onocological treatment measued with GPCCQ 1.0 Scale.
기간: From enrollment before oncological treatment up til 18 months after start of treatment
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The Generic Person-centred Care Questionnaire (GPCCQ) assess patients experiences of Personcentredness in Care.
Totally 18 items assess perceived personcentredness on a likert scale from 1 not at all to 5 completely.
A higher score indicates higher personcentredness.
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From enrollment before oncological treatment up til 18 months after start of treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2029년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
2026년 8월 4일
처음 게시됨 (실제)
2026년 8월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 30일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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