Lung Cancer (Locally Advanced or Metastatic)AcTiFNCT07799974
Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study
An observational study of Lung Cancer (Locally Advanced or Metastatic), run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Locally Advanced or Metastatic)
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Sep 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Francesca Van Hulle, Msc., +32470577042, francesca.vanhulle@ugent.be
About this study
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?
Read more
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.
- Keywords
- Lung cancer, Fatigue, Physical Activity, Rehabilitation
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Fatigue, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue (FACIT-F)
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.
Measured: From enrollment until 4 weeks after the end of treatment
Cancer-related fatigue (EMA)
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.
Measured: From enrollment until 4 weeks after the end of treatment
Physical activity
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.
Measured: From enrollment until 4 weeks after the end of treatment
Secondary outcomes (11)
Symptoms of Dyspnea
Symptoms of dyspnea occurring during daily life activities will be assessed through the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS).
Measured: From enrollment until 4 weeks after the end of treatment
Quality of Life (general)
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.
Measured: From enrollment until 4 weeks after the end of treatment
Quality of Life (lung cancer specific)
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.
Measured: From enrollment until 4 weeks after the end of treatment
Symptoms of stress, anxiety and depression
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.
Measured: From enrollment until 4 weeks after the end of treatment
Sleep quality
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.
Measured: From enrollment until 4 weeks after the end of treatment
Quadriceps strength
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.
Measured: From enrollment until 4 weeks after treatment
Functional exercise capacity
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.
Measured: From enrollment until 4 weeks after treatment
Frailty
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.
Measured: From enrollment until 4 weeks after the end of treatment
Volume of physical activity
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.
Measured: From enrollment until 4 weeks after the end of treatment
Digital Mobility Outcomes (DMOs)
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.
Measured: From enrollment until 4 weeks after the end of treatment
Sleep time
Sleep time will be measured using the Actigraph GT3X, worn on the non-dominant wrist during the night.
Measured: From enrollment until 4 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start14 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799974
- Sponsor's protocol ID
- ONZ-2026-0190
- Acronym
- AcTiF
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT07799974
- Acronym / sponsor ID
- AcTiF / ONZ-2026-0190
- Keywords
- Lung cancer, Fatigue, Physical Activity, Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer-related fatigue (FACIT-F)
Time frame: 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.
Cancer-related fatigue (EMA)
Time frame: 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.
Physical activity
Time frame: 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.
11 secondary outcomes
Symptoms of Dyspnea
Time frame: From enrollment until 4 weeks after the end of treatment
Quality of Life (general)
Time frame: From enrollment until 4 weeks after the end of treatment
Quality of Life (lung cancer specific)
Time frame: From enrollment until 4 weeks after the end of treatment
Symptoms of stress, anxiety and depression
Time frame: From enrollment until 4 weeks after the end of treatment
Sleep quality
Time frame: From enrollment until 4 weeks after the end of treatment
Quadriceps strength
Time frame: From enrollment until 4 weeks after treatment
Functional exercise capacity
Time frame: From enrollment until 4 weeks after treatment
Frailty
Time frame: From enrollment until 4 weeks after the end of treatment
Volume of physical activity
Time frame: From enrollment until 4 weeks after the end of treatment
Digital Mobility Outcomes (DMOs)
Time frame: From enrollment until 4 weeks after the end of treatment
Sleep time
Time frame: From enrollment until 4 weeks after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (Locally Advanced or Metastatic), run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue (FACIT-F) (time frame: From enrollment until 4 weeks after the end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.