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

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 Overview

• Status: Recruiting
• Conditions: Frailty Syndrome

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: lin zeng
• Study Contact Backup: Name: ju qiu, Bachelor.; Phone Number: 18523569369; Email: qiujuchongyi@163.com

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Ju Qiu
    • Contact: ju qiu; Phone Number: 18523569369; Email: qiujuchongyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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".	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.	2023.8~2025.12.

Collaborators and Investigators

• Sponsor: Ju Qiu
• Collaborators: Ministry of Education, China
• Investigators: Principal Investigator: Ling-Na kong, Tutor

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: qiujuchongyi; he Humanities and Social Scien (Other Identifier: Ministry of Education of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study promises to keep the confidentiality of the patient, unless there is a special need, and the patient's consent should be obtained.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No