Cancer Clinical Trial
— GOLD-IOfficial title:
Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
Verified date | November 2022 |
Source | University Hospital Heidelberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - Age from 75 years - G8-Screening <15Pkt - Potentially curative radiotherapy Exclusion Criteria: - no written informed consent - life expectancy< 6 month |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Heidelberg, Radiation Oncology | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiation associated changes in the independence in the activities of daily living | Changes in the Barthel Index | upt to 6 month after radiotherapy | |
Primary | 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 | Therapy associated toxicity | Changes in toxicity assesment according to CTC | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | Sex | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | age | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | Barthel Index | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | Tumor entitiy | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | type of Radiation treatment | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | time of radiation treatment | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | rate of hospitalization Events | during radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | rate of hospitalization events | up to 6 month after radiotherapy | |
Secondary | Analysis of prognostic factors for radiotherapy Treatment success | required medications | up to 6 month after radiotherapy |
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