Geriatric AssessmentNCT06761534
Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients
An observational study of Geriatric Assessment and Geriatric Patients, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study is an observational research. 1. The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Assessment, Geriatric Patients, Patients With Cancer
- What is being tested?
- Screening of comprehensive geriatic assessment., the G8 assessment and Comprehensive Geriatric Assessment (CGA)
- How many people
- 678 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Among all participants, 316 were used to develop the screening tool, 10 for the pre-testing, and 132 for the reliability and validity testing of the screening scale. After the scale was completed, the remaining 220 patients were used for the external validation of the tool. Finally, all patients evaluated using the screening tool were grouped according to different screening results, and the treatment effects and risks among the groups were compared.
Who may be able to join
- Age ≥ 65 years old
- There are clear pathological data to diagnose malignant tumors, and follow-up anti-tumor therapy is determined in this institution
- Have a certain enthusiasm for this study, and voluntarily participate in this study
Who cannot join
- Unable to understand the content of the research
- Unable to cooperate with CGA and screening assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is an observational research.
- The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly cancer patients in China.
- Based on the survey results, an interview outline was developed, and semi-structured interviews were conducted with professional doctors experienced in the diagnosis and treatment of elderly cancer patients to further explore the comprehensive factors influencing the implementation of CGA for this population.
- According to the feedback from the semi-structured interviews, the survey results, and literature reports, the assessment dimensions required for the CGA screening tool were selected. An expert consultation survey questionnaire was designed around these dimensions, and the most suitable assessment items under each dimension were determined using the Delphi expert consultation method.
- The G8 scale was used to assess elderly cancer patients. Items were selected based on their performance to form the screening tool. By setting thresholds and allocating weights for each item, CGA Screening Tool 1.0 was developed.
- Pre-testing and modification of the screening tool were conducted. Investigators used the initially formed screening tool to conduct one-on-one patient testing. Feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility was obtained through consultation with a clinical expert panel to improve and refine its content and management process. This led to the revision and formation of CGA Screening Tool 2.0.
- The reliability and validity of the CGA screening tool were verified using classical measurement theory to ensure the stability, reliability, and effectiveness of the scale tool in practical applications.
- Patients were assessed using both CGA and the screening tool. External validation of Screening Tool 2.0 was performed using CGA as the gold standard to further evaluate the sensitivity, specificity, and accuracy of the screening tool.
- Patients who participated in the assessment during the study were followed up to compare the correlation between different assessment results and patient completion of anti-tumor treatment, treatment efficacy, and the risk of related adverse reactions. The impact of the CGA screening tool on the implementation of CGA and its predictive ability for anti-tumor treatment were explored. Study data were obtained from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, including clinicopathological features such as gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.
- Being tested
- Screening of comprehensive geriatic assessment., the G8 assessment, Comprehensive Geriatric Assessment (CGA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening of comprehensive geriatic assessment.Other
The participants are screened before anti-tumor therapy with a comprehensive assessment screening tool developed for elderly cancer patients, which is more suitable for individualized decision-making in anti-tumor treatment.
the G8 assessmentOther
The G8 is a rapid geriatric screening test that takes only a few minutes to complete. It is used as a calibration standard to validate the novel screening tool in this study.
Comprehensive Geriatric Assessment (CGA)Other
The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Elderly cancer patients | Elderly cancer patients were assessed with the screening tool and G8. If the patient's screening result is positive (frailty risk population), continue with the CGA. Receives: Other: Screening of comprehensive geriatic assessment.; Other: the G8 assessment; Other: Comprehensive Geriatric Assessment (CGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
(Truly frail elderly patients assessed by the novel screening tool and G8) / (Truly frail risk patients + elderly patients with negative results from novel screening tool but actually at risk of frailty after G8 assessment
Measured: Baseline
Secondary outcomes (2)
Accuracy
(The number of elderly patients truly at risk of frailty assessed by the novel screening tool and G8 + the number of elderly patients truly without frailty risk) / Total number of elderly patients in the study
Measured: Baseline
Specificity
(True elderly patients without frailty risk assessed by the novel screening tool and G8) / (True patients without frailty risk + elderly patients with positive results from novel screening tool but actually without frailty risk after G8 screening)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start5 Feb 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 678 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761534
- Sponsor's protocol ID
- EK2023004
- Status last verified
- May 2025
- First submitted
- 28 Dec 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Verification of a Screening Tool for Comprehensive Geriatric Assessment of Elderly Tumor Patients
- ClinicalTrials.gov ID
- NCT06761534
- Acronym / sponsor ID
- EK2023004
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 678 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jan 2025 (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.
This study is an observational research.
- The study first conducted an electronic questionnaire survey among clinicians working in general and specialized hospitals at various levels nationwide to understand the implementation status and influencing factors of comprehensive geriatric assessment (CGA) for elderly cancer patients in China.
- Based on the survey results, an interview outline was developed, and semi-structured interviews were conducted with professional doctors experienced in the diagnosis and treatment of elderly cancer patients to further explore the comprehensive factors influencing the implementation of CGA for this population.
- According to the feedback from the semi-structured interviews, the survey results, and literature reports, the assessment dimensions required for the CGA screening tool were selected. An expert consultation survey questionnaire was designed around these dimensions, and the most suitable assessment items under each dimension were determined using the Delphi expert consultation method.
- The G8 scale was used to assess elderly cancer patients. Items were selected based on their performance to form the screening tool. By setting thresholds and allocating weights for each item, CGA Screening Tool 1.0 was developed.
- Pre-testing and modification of the screening tool were conducted. Investigators used the initially formed screening tool to conduct one-on-one patient testing. Feedback on the tool's clarity, relevance, clinical applicability (localization), and feasibility was obtained through consultation with a clinical expert panel to improve and refine its content and management process. This led to the revision and formation of CGA Screening Tool 2.0.
- The reliability and validity of the CGA screening tool were verified using classical measurement theory to ensure the stability, reliability, and effectiveness of the scale tool in practical applications.
- Patients were assessed using both CGA and the screening tool. External validation of Screening Tool 2.0 was performed using CGA as the gold standard to further evaluate the sensitivity, specificity, and accuracy of the screening tool.
- Patients who participated in the assessment during the study were followed up to compare the correlation between different assessment results and patient completion of anti-tumor treatment, treatment efficacy, and the risk of related adverse reactions. The impact of the CGA screening tool on the implementation of CGA and its predictive ability for anti-tumor treatment were explored. Study data were obtained from the electronic medical record database and hospital information system of Sichuan Cancer Hospital, including clinicopathological features such as gender, age, clinical stage at diagnosis, and information related to anti-tumor treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly cancer patients | – | Other: Screening of comprehensive geriatic assessment., Other: the G8 assessment, Other: Comprehensive Geriatric Assessment (CGA)Elderly cancer patients were assessed with the screening tool and G8. If the patient's screening result is positive (frailty risk population), continue with the CGA. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Among all participants, 316 were used to develop the screening tool, 10 for the pre-testing, and 132 for the reliability and validity testing of the screening scale. After the scale was completed, the remaining 220 patients were used for the external validation of the tool. Finally, all patients evaluated using the screening tool were grouped according to different screening results, and the treatment effects and risks among the groups were compared.
Key inclusion criteria (3 listed)
- Age ≥ 65 years old
- There are clear pathological data to diagnose malignant tumors, and follow-up anti-tumor therapy is determined in this institution
- Have a certain enthusiasm for this study, and voluntarily participate in this study
Key exclusion criteria (2 listed)
- Unable to understand the content of the research
- Unable to cooperate with CGA and screening assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening of comprehensive geriatic assessment.The participants are screened before anti-tumor therapy with a comprehensive assessment screening tool developed for elderly cancer patients, which is more suitable for individualized decision-making in anti-tumor treatment. | Other | Elderly cancer patients |
| the G8 assessmentThe G8 is a rapid geriatric screening test that takes only a few minutes to complete. It is used as a calibration standard to validate the novel screening tool in this study. | Other | Elderly cancer patients |
| Comprehensive Geriatric Assessment (CGA)The participants screened as a high frailty risk will undergo CGA to determine the most appropriate treatment plan. | Other | Elderly cancer patients |
Primary outcome
Sensitivity
Time frame: Baseline
(Truly frail elderly patients assessed by the novel screening tool and G8) / (Truly frail risk patients + elderly patients with negative results from novel screening tool but actually at risk of frailty after G8 assessment
2 secondary outcomes
Accuracy
Time frame: Baseline
Specificity
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Related trials for Geriatric Assessment
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingPhase 3
A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder
Depressive Disorder, Major
Active, not recruitingPhase 3
A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Hypertension, Pulmonary
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Geriatric Assessment and Geriatric Patients, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity (time frame: Baseline). 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 15 May 2025.