Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools

Frailty Syndrome Clinical Trial

— frailty  

Official title:

Comparison of Frailty Screening Performance and Predictive Validity of Adverse Health Outcomes in Breast Cancer Patients Using Frailty Screening Tools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467149
• Other study ID #: qiujuchongyi
• Secondary ID: he Humanities an
• Status: Recruiting
• Start date: August 12, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: Chongqing Medical University
• Contact: ju qiu, Bachelor.
• Phone: 18523569369
• Email: qiujuchongyi[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Communication disorders

• Mental disorders that can't cooperate normally

• Combined with other malignant tumours

• Terminal stage of the disease

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome

Locations

Country	Name	City	State
China	Ju Qiu	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Ju Qiu	Ministry of Education, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	one or more falls due to various reasons between the diagnosis of breast cancer and the second follow-up period.	From 2023.8~2025.12.
Primary	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.	2023.8~2025.12.
Primary	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	From 2023.8~2025.12.
Primary	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.	From 2023.8~2025.12.