Exercise Capacity, Lung Cancer, Physical Activity, Quality of Life
Conditions
Brief summary
This trial investigates the impact of lung cancer treatment on physical status, symptoms and quality of life. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.
Detailed description
Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 150 patients with lung cancer who are undergoing treatment. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy and/or immunotherapy). The aims of the study are to 1. Investigate physical status, before start of treatment in lung cancer patients in comparison with healthy controls (primary outcome). 2. Investigate changes in physical status over the course of treatment in lung cancer patients (primary outcome). 3. Investigate the relationship between changes in physical status with physical activity and symptoms during treatment for lung cancer (secondary outcome). 4. Investigate the relationship between physical status after treatment for lung cancer and comorbidities, hospitalizations and cancer-related and all-cause mortality (exploratory outcome).
Interventions
None listed
Sponsors
Hasselt University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* undergoing treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones) * WHO performance status of maximal 2
Exclusion criteria
* presence of other neoplasms in the last 2 years * bone metastasis * progressive neuromuscular and neurological diseases * unstable cardiac disease * pulmonary hypertension * interstitial lung disease * orthopedic conditions that significantly impair functional status * mental or psychiatric disorders that impair the ability to comply with study procedures. * a history of cerebrovascular accident with remaining functional consequences * a history of lung cancer * difficulties in understanding and speaking Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6MWT | Before start of treatment versus 3 months after treatment initiation |
| 1-minute sit to stand test | Before start of treatment versus 3 months after treatment initiation |
| SPPB | Before start of treatment versus 3 months after treatment initiation |
Secondary
| Measure | Time frame |
|---|---|
| Handgrip strength | Before start of treatment vs. 3 months after treatment initiation |
| Respiratory muscle strength (maximal inspiratory and expiratory pressure) | Before start of treatment vs. 3 months after treatment initiation |
| Daily physical activity (self-reported and accelerometer) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months after treatment initiation |
| Quadriceps strength (isometric and isokinetic) | Before start of treatment vs. 3 months after treatment initiation |
Other
| Measure | Time frame |
|---|---|
| General Health Status (EuroQol 5-dimensions) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 and 1 year months after treatment initiation |
| Daily functioning (Instrumental Activities of Daily Living Scale - IADLS) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months after treatment initiation |
| Fatigue (Multidimensional Fatigue Inventory - MFI-20) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation |
| Dyspnea (San Diego Shortness of Breath Questionnaire (SOBQ)) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation |
| Anxiety and depression (Hospital Anxiety and Depression Scale) | Before start of treatment vs. 3 months after treatment initiation |
| Care needs (Care Dependency Scale) | Before start of treatment vs. 3 months after treatment initiation |
| Depressive symptomatology (Center for Epidemiologic Studies Depression scale (CES-D)) | Before start of treatment vs. 3 months after treatment initiation |
| Dyspnea (modified medical research council scale - MMRC) | Before start of treatment vs.3 months after treatment initiation |
| Comorbidities | Before start of treatment |
| Number of hospital admissions | 12 months after treatment initiation |
| All cause and cancer-related mortality | 12 months after treatment initiation |
| Symptoms (Visual analogue scales) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months and 1 year after treatment initiation |
| Cancer-specific Quality of life (European Organization for the Research and Treatment of Cancer Questionnaire and lung cancer module - EORTC QLQ-C30-LC13) | Before start of treatment vs. during treatment (surgery: during hospitalization; radio: week 2; chemo: beginning of cycle 2 and cycle 4 (each cycle is 3 weeks); immuno: beginning of cycle 2 and cycle 4) vs. 3 months an after treatment initiation |
| General Health Status (12-item Short Form Health Survey - SF-12) | Before start of treatment vs. 3 months after treatment initiation |
Countries
Belgium
Outcome results
None listed