LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| +CGA Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
Other: Comprehensive Geriatric Assessment
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.
|
| -CGA Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
Outcome Measures
Primary Outcome Measures
- Quality of Life (EQ-5D) [12 months]
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.
Secondary Outcome Measures
- Overall Survival (OS) [12 months]
The time from treatment to death, regardless of disease recurrence
- Quality of Life (EQ-5D) [3 months]
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.
- Quality of Life (EQ-5D) [6 months]
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.
- Quality of Life (EQ-5D) [9 months]
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.
- Hand-grip strength [12 months]
Hand-grip strength measured in kilo using a JAMAR hand dynamometer
- Timed-up-and-go (TUG) [12 months]
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
- Chair-stand-test (CST) [12 months]
The CST involves recording the number of "stands" from a chair a person can complete in 30 seconds
- Unplanned Admissions [12 months]
Time to first unplanned admission
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with cytologically or histologically proven non-small cell lung cancer
-
Stage T1-3N0M0
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≥ 70 years old
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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:
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Missing histology/cytology
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Another current malignancy
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Higher staging at treatment planning
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Not able to provide informed consent
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Do not speak or understand Danish
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University Hospital | Aarhus | Aarhus N | Denmark | 8200 |
| 2 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 3 | Odense University Hospital | Odense | Denmark | 5000 | |
| 4 | Vejle Hospital | Vejle | Denmark | 7100 |
Sponsors and Collaborators
- Odense University Hospital
Investigators
- Principal Investigator: Kristian K Bentsen, Dr. med, Department of Oncology, Odense University Hospital, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LIVELUNG