Physical Functioning Throughout Lung Cancer Treatment (LUCAT)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Physical Activity; Lung Cancer; Exercise Capacity

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).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a primary diagnosis of non-small-cell lung cancer who will undergo treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones) and score a maximal of 2 on the WHO performance status classification, will be eligible for inclusion.

Healthy matched volunteers will carry out the same assessments once.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with lung cancer; No study intervention
Healthy controls; No study intervention

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Handgrip strength	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
Respiratory muscle strength (maximal inspiratory and expiratory pressure)	Before start of treatment vs. 3 months after treatment initiation

Other Outcome Measures

Outcome Measure	Time Frame
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
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 (modified medical research council scale - MMRC)	Before start of treatment vs.3 months 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
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
Depressive symptomatology (Center for Epidemiologic Studies Depression scale (CES-D))	Before start of treatment vs. 3 months after treatment initiation

Collaborators and Investigators

• Sponsor: Hasselt University

Publications and helpful links

General Publications

• Quadflieg K, Arents E, Haesevoets S, Van Hulle F, Hermans F, Criel M, Daenen M, Derom E, Spruit MA, Surmont V, Stevens D, Ruttens D, Demeyer H, Burtin C. Impact of cancer treatment on physical functioning, symptoms and health-related quality of life in patients with non-small cell lung cancer: A longitudinal observational study. Respir Med. 2025 Jul 31;247:108283. doi: 10.1016/j.rmed.2025.108283. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimated): July 9, 2015

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Behavior; Lung Neoplasms; Motor Activity
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No