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

Recruiting

• Conditions: Frailty Syndrome

• Registration Number: NCT06467149
• Lead Sponsor: Ju Qiu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-12
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unplanned hospitalisation	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	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
Falls	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".
Depression	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.

Trial Locations

Locations (1)

Ju Qiu; 🇨🇳 Chongqing, China