Clinical trial NCT05187845: Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
Official title: Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Age <70
Keywords: quality of life after radiotherapy
independence after radiotherapy
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Age from 75 years
* G8-Screening \<15Pkt
* Potentially curative radiotherapy

Exclusion Criteria:

* no written informed consent
* life expectancy\< 6 month

Primary outcomes:
measure: Radiation associated changes in the independence in the activities of daily living
timeFrame: upt to 6 month after radiotherapy
measure: Compliance to radiotherapy treatment
timeFrame: through treatment time of radiotherapy, an average of 6 weeks
Secondary outcomes:
measure: Therapy associated toxicity
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: during radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
measure: Analysis of prognostic factors for radiotherapy Treatment success
timeFrame: up to 6 month after radiotherapy
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg, Radiation Oncology
Study officials:
affiliation: University Hospital Heidelberg
name: Jürgen Debus, Prof
role: PRINCIPAL_INVESTIGATOR
References: