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 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
De observación
Inscripción (Estimado)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Bélgica, 9000
- Reclutamiento
- UZ Gent
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Contacto:
- Francesca Van Hulle, Msc.
- Número de teléfono: +32470577042
- Correo electrónico: francesca.vanhulle@ugent.be
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cancer-related fatigue (FACIT-F)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Symptoms of Dyspnea
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de septiembre de 2026
Finalización primaria (Estimado)
1 de agosto de 2028
Finalización del estudio (Estimado)
1 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2026
Publicado por primera vez (Actual)
2 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Procesos Neoplásicos
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Neoplasias Pulmonares
- Fatiga
- Metástasis de neoplasias
- Actividad del motor
Otros números de identificación del estudio
- ONZ-2026-0190
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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