Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy (GOLD-I)

Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie 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.

Study Overview

• Status: Completed
• Conditions: Cancer; Age <70

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University Hospital of Heidelberg, Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

20 patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent
• life expectancy< 6 month

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Investigators: Principal Investigator: Jürgen Debus, Prof, University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ACTUAL): February 1, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (ACTUAL): January 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: quality of life after radiotherapy; independence after radiotherapy
• Other Study ID Numbers: RadOnk_2021_GOLD-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No