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

NCT06467149 | Recruiting DMC

• 2 other identifiers: qiujuchongyihe Humanities and Social Scien
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Communication disorders
• Mental disorders that can't cooperate normally
• Combined with other malignant tumours
• Terminal stage of the disease

Sponsors & Collaborators

• Ju Qiu: lead
• Ministry of Education, China: collaborator

Study Sites (1)

Ju Qiu

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ling-Na kong

  Tutor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ju qiu, Bachelor.

CONTACT

18523569369; qiujuchongyi@163.com

lin zeng

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: August 12, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)