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

Sponsor
Anhui Provincial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05941104
Collaborator
(none)
100
29.6

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: frailty

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Frail group

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.

Non-frail group

Outcome Measures

Primary Outcome Measures

  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.) [baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.]

    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.

Secondary Outcome Measures

  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 Outcome Measures

  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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
Male
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Anhui Provincial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anhui Provincial Hospital
ClinicalTrials.gov Identifier:
NCT05941104
Other Study ID Numbers:
  • ShanShan Liu
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023