Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy

Study Overview
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Brief Summary
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Elderly patients * with multiple comorbidities are underrepresented in most radio-oncology studies. In times of individualized therapy and when weighing up oncological over- or under-therapy, this observational study is a step towards the implementation of established geriatric instruments and concepts in radiation oncology. As part of the initial outpatient consultation on radiotherapy, the quality of life of patients older than 70 years before the start of therapy is assessed using the EORTC QLQ-C30 and ELD14 questionnaires. Furthermore, a geriatric screening is carried out using the G8 questionnaire. The geriatric screening carried out in routine clinical practice with little effort is used to filter out patients with no risk of increased vulnerability - these participants do not require any further examinations.

Detailed Description
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Vulnerable patients with deficits (G8 score <15 pts) receive a geriatric assessment (Comprehensive geriatric assessment (CGA)) consisting of abbreviated comprehensive geriatric assessment (aCGA), appetite (Mini Nutritional Assessment (short form = MNA-SF)) at the beginning and end of radiotherapy ), physical functionality (Short physical performance battery) and measurement of hand strength. In addition, these patients receive an individualized inpatient geriatric-oncological complex treatment, which is already implemented analogous to the palliative complex treatment. The patients receive targeted support from trained nursing staff, social services, physiotherapy, nutritional advice, hospital pharmacies and psycho-oncology. At the end of the oncological therapy and for the first aftercare after the end of therapy, the questionnaires on quality of life are filled out again in order to analyze changes. Initially, 20 patients are to be treated in a first phase (feasibility) in this concept of geriatric-oncological complex treatment in order to build up and expand the necessary structures for an interdisciplinary complex treatment and to set parameters for adherence to the therapy concept and maintaining quality of life and independence in the activities of the daily life for this collective of patients. As part of a follow-up study, vulnerable patients are then to be stratified and randomized using these parameters so that a more detailed analysis is possible.

Official Title
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Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy

Conditions
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Cancer, Age <70

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 75 years G8-Screening <15Pkt Potentially curative radiotherapy Exclusion Criteria: no written informed consent life expectancy< 6 month

Ages Eligible for Study
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Minimum Age: 75 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation associated changes in the independence in the activities of daily living | Changes in the Barthel Index | upt to 6 month after radiotherapy | 
| Compliance to radiotherapy treatment | number of Events of premature termination of planned radiotherapy treatment | through treatment time of radiotherapy, an average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy associated toxicity | Changes in toxicity assesment according to CTC | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | Sex | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | age | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | Barthel Index | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | Tumor entitiy | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | type of Radiation treatment | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | time of radiation treatment | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | rate of hospitalization Events | during radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | rate of hospitalization events | up to 6 month after radiotherapy | 
| Analysis of prognostic factors for radiotherapy Treatment success | required medications | up to 6 month after radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life after radiotherapy, independence after radiotherapy