Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study (AcTiF)
2026年9月16日 更新者：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.
調査の概要
状態
募集
研究の種類
観察的
入学 (推定)
50
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Oost-Vlaanderen
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Ghent、Oost-Vlaanderen、ベルギー、9000
- 募集
- UZ Gent
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コンタクト：
- Francesca Van Hulle, Msc.
- 電話番号：+32470577042
- メール：francesca.vanhulle@ugent.be
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cancer-related fatigue (FACIT-F)
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Cancer-related fatigue (EMA)
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Physical activity
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Symptoms of Dyspnea
時間枠：From enrollment until 4 weeks after the end of treatment
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Symptoms of dyspnea occurring during daily life activities will be assessed through the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS).
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From enrollment until 4 weeks after the end of treatment
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Quality of Life (general)
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Quality of Life (lung cancer specific)
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Symptoms of stress, anxiety and depression
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Sleep quality
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Quadriceps strength
時間枠：From enrollment until 4 weeks after treatment
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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.
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From enrollment until 4 weeks after treatment
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Functional exercise capacity
時間枠：From enrollment until 4 weeks after treatment
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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.
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From enrollment until 4 weeks after treatment
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Frailty
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Volume of physical activity
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Digital Mobility Outcomes (DMOs)
時間枠：From enrollment until 4 weeks after the end of treatment
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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.
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From enrollment until 4 weeks after the end of treatment
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Sleep time
時間枠：From enrollment until 4 weeks after the end of treatment
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Sleep time will be measured using the Actigraph GT3X, worn on the non-dominant wrist during the night.
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From enrollment until 4 weeks after the end of treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
時間枠：From enrollment until 1 year after the start of the study
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The occurrence of (re)hospitalization, all-cause mortality and cancer-related mortality in the year after the start of the study will be reported.
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From enrollment until 1 year after the start of the study
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月14日
一次修了 (推定)
2028年8月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年8月24日
QC基準を満たした最初の提出物
2026年8月28日
最初の投稿 (実際)
2026年9月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月17日
QC基準を満たした最後の更新が送信されました
2026年9月16日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。