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 september 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Studietype
Observationeel
Inschrijving (Geschat)
50
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, België, 9000
- Werving
- UZ Gent
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Contact:
- Francesca Van Hulle, Msc.
- Telefoonnummer: +32470577042
- E-mail: francesca.vanhulle@ugent.be
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Cancer-related fatigue (FACIT-F)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Symptoms of Dyspnea
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 september 2026
Primaire voltooiing (Geschat)
1 augustus 2028
Studie voltooiing (Geschat)
1 oktober 2028
Studieregistratiedata
Eerst ingediend
24 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 augustus 2026
Eerst geplaatst (Werkelijk)
2 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 september 2026
Laatste update ingediend die voldeed aan QC-criteria
16 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Neoplastische processen
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Longneoplasmata
- Vermoeidheid
- Neoplasma metastase
- Motorische activiteit
Andere studie-ID-nummers
- ONZ-2026-0190
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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