Comprehensive Geriatric Assessment, Non-small Cell Lung Cancer, Stereotactic Body Radiotherapy
Conditions
Keywords
NSCLC, SBRT, CGA
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.
Interventions
OTHERComprehensive 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.
Sponsors
Odense University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hand-grip strength | 12 months | Hand-grip strength measured in kilo using a JAMAR hand dynamometer |
| Overall Survival (OS) | 12 months | The time from treatment to death, regardless of disease recurrence |
| 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 |
| 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 |
Countries
Denmark
Contacts
Primary ContactKristian K Bentsen, Dr.med.
Backup ContactStefan S Jeppesen, Dr.med
Outcome results
None listed