Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study

Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational 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?

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.

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.