Frailty SyndromefrailtyNCT06467149
Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools
An observational study of Frailty Syndrome, run by Ju Qiu at 1 site in China.
Trial summary
This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty Syndrome
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2023to 30 Dec 2025
- How long will I take part?
- 1 Year
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical assessment and data collection of older adults over 50 years of age with breast cancer diagnosed at a tertiary hospital in China, with no comorbidities of other malignancies.
Who may be able to join
- Clinical diagnosis of breast cancer
- Age ≥50 years old
- the treatment plan discussed by MDT includes surgery and chemotherapy
- can walk on their own (with the assistance of walking aids)
Who cannot join
- Communication disorders
- Mental disorders that can't cooperate normally
- Combined with other malignant tumours
- Terminal stage of the disease
Trial locations and contacts
1 site in 1 country.
lin zeng contact
China1 site, 1 recruiting
- Recruiting
Ju Qiu
Chongqing
ju qiu, 18523569369, qiujuchongyi@163.com
About this study
This study uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.
- Conditions
- Frailty Syndrome
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| To select a suitable frailty screening scale for future frailty screening of breast cancer patients | Only basic inquiries and measurements are performed on the patient, without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
one or more falls due to various reasons between the diagnosis of breast cancer and the second follow-up period.Does not use any scale, is a dichotomous variable with a fall score of "1" and a no fall score of "0".
Measured: From 2023.8~2025.12.
Unplanned hospitalisation
hospitalisation after doctor's diagnosis and hospitalisation for more than one day after diagnosis of breast cancer up to the second follow-up period, except for treatment nodes such as surgery and chemotherapy.No scale is used, it is a dichotomous variable with a score of "1" for unplanned hospitalisation and a score of "0" for non-occurrence.
Measured: 2023.8~2025.12.
Disability
Activities of daily living (ADL) were assessed using the Barthel Index (BI).The present study defined the development of disability as a decrease in scores on at least one scale entry in the BI scale from six months earlier
Measured: From 2023.8~2025.12.
Depression
Depression screening was performed using the Geriatric Depression Scales-5 (GDS-5). The options for each entry were "yes" or "no". Entry 1 was scored 0 points for "yes" and 1 point for "no", and entries 2 to 5 were scored 1 point for "yes" and 0 points for "no". The answer "yes" for entries 2 to 5 is 1 point, and the answer "no" is 0 points. The total score ranged from 0 to 5, with a score of ≥2 indicating the presence of depression.
Measured: From 2023.8~2025.12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start12 Aug 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ju Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, China
- Responsible party
- Sponsor-investigator, Ju Qiu, Chongqing Medical University
- Investigators
- Ling-Na kong, Principal investigator, Tutor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467149
- Sponsor's protocol ID
- qiujuchongyi
- Other IDs
- he Humanities and Social Scien
- Acronym
- frailty
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study promises to keep the confidentiality of the patient, unless there is a special need, and the patient's consent should be obtained.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools
- ClinicalTrials.gov ID
- NCT06467149
- Acronym / sponsor ID
- frailty / qiujuchongyi
- Conditions
- Frailty Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ju QiuUniversity, hospital or other
- Collaborators
- Ministry of Education, China
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jun 2024 (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 uses the Physical Frailty Phenotype (PFP) as the diagnostic criterion for frailty and aims to explore the frailty screening scale FRAIL (The FRAIL Scale), Tilburg Frailty Index (TFI) and geriatric screening. Screening performance of Tool-8 (Geriatric-8, G-8) in breast cancer patients, to compare the predictive validity of different frailty screening scales for adverse health outcomes in breast cancer patients, and to select appropriate frailty screening methods for breast cancer patients in my country Screening scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To select a suitable frailty screening scale for future frailty screening of breast cancer patients | – | –Only basic inquiries and measurements are performed on the patient, without any intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical assessment and data collection of older adults over 50 years of age with breast cancer diagnosed at a tertiary hospital in China, with no comorbidities of other malignancies.
Key inclusion criteria (4 listed)
- Clinical diagnosis of breast cancer
- Age ≥50 years old
- the treatment plan discussed by MDT includes surgery and chemotherapy
- can walk on their own (with the assistance of walking aids)
Key exclusion criteria (4 listed)
- Communication disorders
- Mental disorders that can't cooperate normally
- Combined with other malignant tumours
- Terminal stage of the disease
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
Falls
Time frame: From 2023.8~2025.12.
one or more falls due to various reasons between the diagnosis of breast cancer and the second follow-up period.Does not use any scale, is a dichotomous variable with a fall score of "1" and a no fall score of "0".
Unplanned hospitalisation
Time frame: 2023.8~2025.12.
hospitalisation after doctor's diagnosis and hospitalisation for more than one day after diagnosis of breast cancer up to the second follow-up period, except for treatment nodes such as surgery and chemotherapy.No scale is used, it is a dichotomous variable with a score of "1" for unplanned hospitalisation and a score of "0" for non-occurrence.
Disability
Time frame: From 2023.8~2025.12.
Activities of daily living (ADL) were assessed using the Barthel Index (BI).The present study defined the development of disability as a decrease in scores on at least one scale entry in the BI scale from six months earlier
Depression
Time frame: From 2023.8~2025.12.
Depression screening was performed using the Geriatric Depression Scales-5 (GDS-5). The options for each entry were "yes" or "no". Entry 1 was scored 0 points for "yes" and 1 point for "no", and entries 2 to 5 were scored 1 point for "yes" and 0 points for "no". The answer "yes" for entries 2 to 5 is 1 point, and the answer "no" is 0 points. The total score ranged from 0 to 5, with a score of ≥2 indicating the presence of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No. The study promises to keep the confidentiality of the patient, unless there is a special need, and the patient's consent should be obtained.
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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.
lin zeng contact
Ling-Na kong principal investigator
Tutor
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 Frailty Syndrome, run by Ju Qiu 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ju qiu, Bachelor. (18523569369, qiujuchongyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: From 2023.8~2025.12.). The study lists 4 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 24 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.