CancerGOLD-INCT05187845
Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
An observational study of Cancer and Age <70, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 20 patients
Who may be able to join
- Age from 75 years
- G8-Screening <15Pkt
- Potentially curative radiotherapy
Who cannot join
- no written informed consent
- life expectancy< 6 month
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
About this study
Official title: 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.
Read the 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.
- Keywords
- quality of life after radiotherapy, independence after radiotherapy
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation associated changes in the independence in the activities of daily living
Changes in the Barthel Index
Measured: upt to 6 month after radiotherapy
Compliance to radiotherapy treatment
number of Events of premature termination of planned radiotherapy treatment
Measured: through treatment time of radiotherapy, an average of 6 weeks
Secondary outcomes (10)
Therapy associated toxicity
Changes in toxicity assesment according to CTC
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Sex
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
age
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Barthel Index
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Tumor entitiy
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
type of Radiation treatment
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
time of radiation treatment
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
rate of hospitalization Events
Measured: during radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
rate of hospitalization events
Measured: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
required medications
Measured: up to 6 month after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Jürgen Debus, Prof, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187845
- Sponsor's protocol ID
- RadOnk_2021_GOLD-I
- Acronym
- GOLD-I
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatrisch-Onkologische Studie Zur Lebensqualität Und Selbstständigkeit Nach Radiotherapie Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy
- ClinicalTrials.gov ID
- NCT05187845
- Acronym / sponsor ID
- GOLD-I / RadOnk_2021_GOLD-I
- Keywords
- quality of life after radiotherapy, independence after radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 20 patients
Key inclusion criteria (3 listed)
- Age from 75 years
- G8-Screening <15Pkt
- Potentially curative radiotherapy
Key exclusion criteria (2 listed)
- no written informed consent
- life expectancy< 6 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
10 secondary outcomes
Therapy associated toxicity
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: during radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Analysis of prognostic factors for radiotherapy Treatment success
Time frame: up to 6 month after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Debus, Prof principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Age <70, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation associated changes in the independence in the activities of daily living (time frame: upt to 6 month after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.