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

NCT05941104 | Unknown

• 1 other identifier: ShanShan Liu
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
2. 2.Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.

Conditions

Prostatic Neoplasms; Frailty; Blood Biological Indicators; Quality of Life; Survival

Outcome Measures

Primary Outcomes (1)

• 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 α 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 Outcomes (1)

• Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, 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.

Other Outcomes (1)

• 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.

Study Arms (2)

Frail group

Other: frailty

Non-frail group

Interventions

frailty OTHER

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.

Frail group

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer patients with Radical Prostatectomy.

You may qualify if:

• Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
• Radical prostatectomy is planned;
• Voluntarily sign the informed consent form.

You may not qualify if:

• Diagnosed with other malignant tumors at the same time;
• Patients with acute infection.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 12, 2023
• Study Start: July 15, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 12, 2023

Record last verified: 2023-06