University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120, Germany
NCT Number: NCT05187845
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.
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Notify MeVulnerable 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: upt to 6 month after radiotherapy
Changes in the Barthel Index
Time frame: through treatment time of radiotherapy, an average of 6 weeks
number of Events of premature termination of planned radiotherapy treatment
Time frame: up to 6 month after radiotherapy
Changes in toxicity assesment according to CTC
Time frame: up to 6 month after radiotherapy
Sex
Time frame: up to 6 month after radiotherapy
age
Time frame: up to 6 month after radiotherapy
Barthel Index
Time frame: up to 6 month after radiotherapy
Tumor entitiy
Time frame: up to 6 month after radiotherapy
type of Radiation treatment
Time frame: up to 6 month after radiotherapy
time of radiation treatment
Time frame: during radiotherapy
rate of hospitalization Events
Time frame: up to 6 month after radiotherapy
rate of hospitalization events
Time frame: up to 6 month after radiotherapy
required medications
University Hospital Heidelberg
Other
Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
Acronym: GOLD-I
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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