Identification of Changes in Cancer-related Fatigue and Physical Activity and Their Association in Patients With Inoperable Lung Cancer: a Longitudinal Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Ghent
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cancer-related fatigue (FACIT-F)
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary 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)
- Quadriceps strength(From enrollment until 4 weeks after treatment)
- Functional exercise capacity(From enrollment until 4 weeks after treatment)
- Frailty(From enrollment until 4 weeks after the end of treatment)
- Volume of physical activity(From enrollment until 4 weeks after the end of treatment)
- Digital Mobility Outcomes (DMOs)(From enrollment until 4 weeks after the end of treatment)
- Sleep time(From enrollment until 4 weeks after the end of treatment)