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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)

16 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

50

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgio, 9000

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cancer-related fatigue (FACIT-F)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Symptoms of Dyspnea
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Ghent

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 settembre 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 agosto 2026

Primo Inserito (Effettivo)

2 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ONZ-2026-0190

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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