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Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study (AcTiF)

2026년 9월 16일 업데이트: University Hospital, Ghent

The goal of this observational study is to learn how fatigue changes during lung cancer treatment and how it relates to physical activity levels in adults with locally advanced, inoperable, or metastatic lung cancer who are starting chemotherapy and/or immunotherapy. The main questions to answer are:

  • How do fatigue and physical activity levels change throughout lung cancer treatment?
  • How are changes in fatigue related to physical activity levels on the short- and long term?

Participants will:

  • Complete questionnaires on fatigue, breathlessness, sleep quality, quality of life, stress, anxiety and depression at multiple time points.
  • Wear activity monitors during four measurement periods to assess daily physical activity.
  • Complete brief daily smartphone questionnaires on fatigue, breathlessness, pain, and perceived ability to walk.
  • Wear a smartwatch throughout the study.
  • Undergo physical assessments, including a 1-minute sit-to-stand test, a thigh muscle strength test, and a frailty assessment.
  • Attend six study visits over the course of the study, some of which may be scheduled alongside routine hospital appointments.

연구 개요

상태

모병

정황

연구 유형

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 벨기에
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, 벨기에, 9000

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

비확률 샘플

연구 인구

This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).

설명

Inclusion Criteria:

  • Locally advanced irresectable or metastatic lung cancer (all histologies including NSCLC and SCLC).
  • ≥18 years.
  • ECOG performance status of ≤2 (a lower score indicates a higher performance status), assessed by the clinician (10).
  • Planned to start a first-line systemic treatment consisting of chemotherapy and/or immunotherapy. Patients who receive radiotherapy, concurrently or sequentially, within a multimodality treatment approach for locally advanced lung cancer are allowed.
  • Ability to give informed consent.

Exclusion Criteria:

  • Being planned for primary radiotherapy with radical intent only or treatment with targeted therapies (mostly tyrosine kinase inhibitors (TKI's)).
  • Having complicated or unstable bone metastases (as judged by the clinician).
  • Unstable heart disease, including unstable congestive heart failure, arrythmia, or myocardial infarction diagnosed within the last 3 months.
  • Other malignancies in the last 2 years (except for adequately treated basal cell, superficial or in situ cancer of the bladder or the cervix).
  • Have musculoskeletal problems precluding them to be physically active.
  • Not understanding and speaking Dutch.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cancer-related fatigue (FACIT-F)
기간: From enrollment until 4 weeks after the end of treatment
Cancer-related fatigue (CRF) will be measured using the FACIT-F and EMA. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire with each item answered on a 5-point rating scale, which has been validated and frequently used in cancer populations. The questionnaire is based on a 7-day recall period. Scores range between 0 and 52, where higher scores represent lower fatigue levels. The minimum important difference for the FACIT-F is between 3 to 4 points.
From enrollment until 4 weeks after the end of treatment
Cancer-related fatigue (EMA)
기간: From enrollment until 4 weeks after the end of treatment
Regarding EMA, patients will install the m-path application on their smartphone. Patients will be asked to fill in 3 prompts per day for 15 (M1 and M2) or 8 (M3 and M4) consecutive days, answering questions about fatigue ("I feel fatigued right now" from 1 (not at all) to 7 (very)). The 3 prompts will be sent at a random time within 3 blocks per day (between 8h and 10h, between 12h and 14h, and between 18h and 20h). Prompts will be available for 30 minutes and a reminder will be sent after 15 minutes. Daily symptom rating will be calculated by taking the average of the 3 prompts and will be used for further analyses.
From enrollment until 4 weeks after the end of treatment
Physical activity
기간: From enrollment until 4 weeks after the end of treatment
Physical activity (PA) will be measured during one or two week(s) (depending on the treatment phase) using an Actigraph GT3X and Dynaport Movemonitor+, both validated accelerometers. Following recommendations on wear location, participants will be asked to wear the devices at the waist (on the same belt) during daytime and switch the Actigraph GT3X to the non-dominant wrist during the night (to measure sleep duration). Valid PA data is considered when a patient has at least 8 hours wear time during waking hours. The average daily step count (based on Dynaport Movemonitor+) and minutes of MVPA (based on Actigraph GTX3) per day of all valid days are the PA outcomes.
From enrollment until 4 weeks after the end of treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Symptoms of Dyspnea
기간: From enrollment until 4 weeks after the end of treatment
Symptoms of dyspnea occurring during daily life activities will be assessed through the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS).
From enrollment until 4 weeks after the end of treatment
Quality of Life (general)
기간: From enrollment until 4 weeks after the end of treatment
The European organization for the Research and Treatment of Cancer Questionnaire (EORTC QLQ-C30) is a clinically valid and useful tool for assessing quality of life in lung cancer patients.
From enrollment until 4 weeks after the end of treatment
Quality of Life (lung cancer specific)
기간: From enrollment until 4 weeks after the end of treatment
The European organization for the Research and Treatment of Cancer Questionnaire - lung cancer module (EORTC QLQ-LC13) is a clinically valid and useful tool for assessing quality of life, specifically for lung cancer patients.
From enrollment until 4 weeks after the end of treatment
Symptoms of stress, anxiety and depression
기간: From enrollment until 4 weeks after the end of treatment
The Depression Anxiety Stress Scales-21 (DASS-21) has been developed as a single screening tool to measure comorbid depression, anxiety, and stress disorders in healthy individuals and represent a psychometrically viable option for health systems and clinicians when assessing distress in cancer patients.
From enrollment until 4 weeks after the end of treatment
Sleep quality
기간: From enrollment until 4 weeks after the end of treatment
The Pittsburgh Sleep Quality Index (PSQI) is a valid and reliable tool to assess sleep quality across diverse populations. Total scores range from 0 - 20, with a score of 5 or more indicating a poor sleep quality.
From enrollment until 4 weeks after the end of treatment
Quadriceps strength
기간: From enrollment until 4 weeks after treatment
A hand-held dynamometer (Microfet, Biometrics, NL) will be used to assess right isometric quadriceps strength. Patients will be tested while sitting in an upright position. The make test, as described by the ERS/ATS guidelines, will be performed. The best of at least three reproducible measurements (<10% variability) will be used for analyses.
From enrollment until 4 weeks after treatment
Functional exercise capacity
기간: From enrollment until 4 weeks after treatment
Functional exercise capacity will be measured by a 1-min sit-to-stand (1MSTS) test and is a reliable and valid test for measuring functional exercise capacity in COPD patients. Each participant will perform the test twice, with the highest value used for subsequent analyses. Before and after the test, dyspnoea and fatigue will be monitored using the BORG-scale. The heart rate and SpO2 will be monitored continuously throughout the test.
From enrollment until 4 weeks after treatment
Frailty
기간: From enrollment until 4 weeks after the end of treatment
Frailty will be assessed according to the criteria of Fried et al. The frailty phenotype is identified by the presence of three or more of the following components. Unintentional weight loss, exhaustion, low activity, slowness and weakness. Cut-off values for slowness and weakness were defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) recommendations.
From enrollment until 4 weeks after the end of treatment
Volume of physical activity
기간: From enrollment until 4 weeks after the end of treatment
Patients will be asked to wear a wearable (Garmin Vivosmart 5) throughout the whole study period as a measure of total volume of PA. Whereas wearables will not provide a valid outcome to be used as primary outcome, the data are valid to provide an overall measure of physical activity.
From enrollment until 4 weeks after the end of treatment
Digital Mobility Outcomes (DMOs)
기간: From enrollment until 4 weeks after the end of treatment
The DMOs, more specifically, gait pace, gait rhythm and gait bout-to-bout variability will be measured using the Dynaport Movemonitor +. This outcome measure is part of the PA measurement and therefore requires no additional measurement.
From enrollment until 4 weeks after the end of treatment
Sleep time
기간: From enrollment until 4 weeks after the end of treatment
Sleep time will be measured using the Actigraph GT3X, worn on the non-dominant wrist during the night.
From enrollment until 4 weeks after the end of treatment

기타 결과 측정

결과 측정
측정값 설명
기간
Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
기간: From enrollment until 1 year after the start of the study
The occurrence of (re)hospitalization, all-cause mortality and cancer-related mortality in the year after the start of the study will be reported.
From enrollment until 1 year after the start of the study

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Hospital, Ghent

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)

2026년 9월 14일

기본 완료 (추정된)

2028년 8월 1일

연구 완료 (추정된)

2028년 10월 1일

연구 등록 날짜

최초 제출

2026년 8월 24일

QC 기준을 충족하는 최초 제출

2026년 8월 28일

처음 게시됨 (실제)

2026년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ONZ-2026-0190

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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