LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT

Study Overview
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Brief Summary
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Older patients with non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) often die from other causes than lung cancer due to age-related comorbidities. This national randomized study will include 130 patients throughout 5 Danish cancer centres and investigate if a comprehensive geriatric intervention (CGA) when added upfront to SBRT for patients with localized NSCLC will have an impact on quality of life (QoL), overall survival, physical functionality and unplanned hospital admissions. If an upfront CGA improves patients' general health status, this study could lead to implementation of a CGA in standard clinical practice as well as further research on older patients receiving radiotherapy.

Official Title
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LIVELUNG - Impact of CGA on QoL, Overall Survival and the Need for Admission in Patients Diagnosed With Localized NSCLC Treated With SBRT - a National Randomized Study

Conditions
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Non-small Cell Lung Cancer, Stereotactic Body Radiotherapy, Comprehensive Geriatric Assessment

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cytologically or histologically proven non-small cell lung cancer Stage T1-3N0M0 ≥ 70 years old In a multidisciplinary setting the patient is considered medically inoperable, too frail for operation due to age and/or comorbidity or that the patient refuse surgery and therefore candidate for SBRT. Exclusion Criteria: Missing histology/cytology Another current malignancy Higher staging at treatment planning Not able to provide informed consent Do not speak or understand Danish

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| +CGA<br>Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA) | Other: Comprehensive Geriatric Assessment<br>* Comprehensive geriatric assessment (CGA) is defined as a multidisciplinary diagnostic and treatment process that identifies medical, psychosocial, and functional capabilities of an older adult in order to develop a coordinated plan to maximize overall health with aging.<br>|
| -CGA<br>Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (EQ-5D) | Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The time from treatment to death, regardless of disease recurrence | 12 months | 
| Quality of Life (EQ-5D) | Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status. | 3 months | 
| Quality of Life (EQ-5D) | Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status. | 6 months | 
| Quality of Life (EQ-5D) | Questionnaire with 5 dimensions each with 5 (1-5) levels representing the health status of the patient and the patients self-rated health status on a scale from 0-100 (EQ VAS). The score of the 5 dimensions can be converted into a single index value 0-1 with higher values indicating poorer health status. | 9 months | 
| Hand-grip strength | Hand-grip strength measured in kilo using a JAMAR hand dynamometer | 12 months | 
| Timed-up-and-go (TUG) | TUG consists of timing (seconds) a patient getting up from a chair from the sitting to the bipedal position, walking three meters, turning, returning, and sitting on the chair again | 12 months | 
| Chair-stand-test (CST) | The CST involves recording the number of stands from a chair a person can complete in 30 seconds | 12 months | 
| Unplanned Admissions | Time to first unplanned admission | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, SBRT, CGA