The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

Quality of Life Clinical Trial

Official title:

The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05941104
• Other study ID #: ShanShan Liu
• Status: Not yet recruiting
• Start date: July 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Anhui Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy. The main questions it aims to answer are: 1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically. 2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy. Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Gender: Male
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);

2. Radical prostatectomy is planned;

3. Voluntarily sign the informed consent form.

Exclusion Criteria:

1. Diagnosed with other malignant tumors at the same time;

2. Patients with acute infection.

Related Conditions & MeSH terms

• Frailty
• Prostatic Neoplasms
• Quality of Life
• Survival

Intervention

Other:
• frailty
Frailty is a group of common clinical syndromes in the elderly, characterized by systematic, dynamic and reversible, the core of which is the decline of physiological reserves and the destruction of self-balance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Surviving up to 2 years		From date of hospitalization until the date of death from any cause, assessed up to 2 years.
Primary	Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)	Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach a coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.	baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Secondary	Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-a, PSA and et al)		baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.