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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| +CGA | Patients randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
| |
| -CGA | Patients not randomised to undergo a Comprehensive Geriatric Assessment (CGA) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients, able to provide informed consent, aged ≥70 diagnosed with T1-3N0M0 NSCLC considered medically inoperable at a multidisciplinary setting and therefore candidates for SBRT. 130 patients will be included in a period of 24 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristian K Bentsen, Dr.med. | Contact | 004528735210 | kristian.kirkelund.bentsen3@rsyd.dk | |
| Stefan S Jeppesen, Dr.med | Contact | 004530502948 | Stefan.Jeppesen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Kristian K Bentsen, Dr. med | Department of Oncology, Odense University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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|
| 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 |
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| Vejle Hospital | Recruiting | Vejle | 7100 | Denmark |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |