NCT07799974|Recruiting
Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study
AcTiF
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AcTiF
Sponsor study identifier
observational
50
1 country
1
Study Start
September 14, 2026
Actual (reported)Primary Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2026
Actual (reported)September 2, 2026
Actual (reported)September 14, 2026
Actual (reported)August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
Symptoms of Dyspnea
From enrollment until 4 weeks after the end of treatment
Quality of Life (general)
From enrollment until 4 weeks after the end of treatment
Quality of Life (lung cancer specific)
From enrollment until 4 weeks after the end of treatment
Symptoms of stress, anxiety and depression
From enrollment until 4 weeks after the end of treatment
Sleep quality
From enrollment until 4 weeks after the end of treatment
Occurence of (re)hospitalization, all-cause mortality and cancer-related mortality
From enrollment until 1 year after the start of the study
This study will include patients with locally advanced irresectable or metastatic lung cancer, who are planned to undergo systemic treatment (chemotherapy and/or immunotherapy).
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
First Submitted
August 24, 2026
First Posted
September 2, 2026
Study Start
September 14, 2026
Actual (reported)Primary Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Phase 1 First-in-Human Study of CRPA1A2, a MAGE-A1/HLA-A*02:01 Bispecific T-Cell Engager, in Patients With Solid Tumors
From enrollment until 4 weeks after the end of treatment
Contact the study team to confirm eligibility.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 17, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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