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In a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed.
Primary objective: Fragility is assessed using the G8 questionnaire.
Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected.
In this prospective study patients with a tumor of the head and neck region, that are planned for Surgery or radiotherapy (chemotherapy) will be included. The probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. In addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. Due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects In order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. In addition, we want to determine influencing factors that are associated with fragility. These include, for example, difficulty swallowing and weight loss. Based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric Assessment | Experimental | Frailty is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric Assessment | Other | Frailty is assessed using the G8 questionnaire. Secondary objectives include the assessment of quality of life and financial burden (EORTC-QLQ C30+ H&N43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. Epidemiological and disease-related data is also collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Frailty | Assessment via G8 (Geriatric Screening Tool) questionnaire consists of 8 questions. The score ranges from 0 (poor score) to 17 points (good score), and a score of 11 or lower indicated frailty, whereas a score between 12 and 14 equals pre-frail patients. Patients with a score above 14 are considert non-frail. | once prior to surgery or at beginning of radiation |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC-QLQ C30 questionnaire | EORTC-QLQ C30 questionnaire consist of 30 questions with a score range from 0 to 100. Higher scores represents better quality of life, low scores indicating lower quality of life. | prior to surgery or at beginning of radiotherapy |
| swallowing function |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for performing a 6MWT:
Absolute contraindications* for the procedure are
Relative contraindications are
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Medicine Berlin | Berlin | State of Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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|
Questionnaire (M.D. Anderson Dysphagia Inventory), scores range from 20 (poor function) to 100 (high function) |
| prior to surgery or beginning of radiation |
| Cardio-pulmonary resilience | 6-Minute Walk test | prior to surgery or beginning of radiation |
| Epidemiologic Data | Descriptive (e.g. income, alcohol use, smoking status), epidemiologic data is not scored | prior to surgery or beginning of radiation |
| Information on current tumor disease | number of patients with T1/T2/T3/T4 Tumor Stage and N1/N2/N3 lymphonodal stage | prior to surgery or beginning of radiation |
| EORTC-H&N43 questionnaire | EORTC-H&N43 questionnaires. Scores are from 0 to 100. A high score indicates high level of symptamotology. | prior to surgery or at beginning of radiotherapy |
| 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 |