Skip to main content
OpenTrials
Completed

NCT Number: NCT05187845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no written informed consent
  • life expectancy< 6 month

Treatment and study plan

Primary outcomes

  1. Radiation associated changes in the independence in the activities of daily living

    Time frame: upt to 6 month after radiotherapy

    Changes in the Barthel Index

  2. Compliance to radiotherapy treatment

    Time frame: through treatment time of radiotherapy, an average of 6 weeks

    number of Events of premature termination of planned radiotherapy treatment

Secondary outcomes

  1. Therapy associated toxicity

    Time frame: up to 6 month after radiotherapy

    Changes in toxicity assesment according to CTC

  2. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    Sex

  3. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    age

  4. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    Barthel Index

  5. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    Tumor entitiy

  6. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    type of Radiation treatment

  7. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    time of radiation treatment

  8. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: during radiotherapy

    rate of hospitalization Events

  9. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    rate of hospitalization events

  10. Analysis of prognostic factors for radiotherapy Treatment success

    Time frame: up to 6 month after radiotherapy

    required medications

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

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

Acronym: GOLD-I

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.