Comprehensive Study on the Quality of Life in Cervical Cancer Patients

Quality of Life Clinical Trial

Official title:

Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03967457
• Other study ID #: CCQOL
• Status: Recruiting
• Start date: June 19, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary uterine cervical carcinomas

• Aged 18 or older

• Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center

• Informed consents delivered

Exclusion Criteria:

• Not meeting any of the inclusion criteria

• Not accepting any of the four kinds of evaluations for quality of life

• Recurrent patients

• Not achieving response after above major therapy

Related Conditions & MeSH terms

• Cervical Cancer
• Disease-free Survival
• Ovarian Reserve Function
• Overall Survival
• Pelvic Floor Disorders
• Quality of Life
• Rectum Dynamics
• Sex Dysfunction
• Survivorship
• Urodynamics
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• questionnaires survey
Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)
• Urodynamic testing
Urodynamic testing consists of important urodynamic parameters including: Bladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume
• Rectum dynamics testing
Rectum dynamics testing consists of important parameters of rectum activities
• ovarian reserve function
Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores from EORTC QLQ-C30	Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.
Primary	Scores from EORTC QLQ-CX24	Scores calculated from EORTC QLQ-CX24	Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.
Secondary	Concentration of follicle-stimulating hormone	Follicle-stimulating hormone tested in peripheral blood	Change from the baseline of four weeks before major therapy at following-up
Secondary	Concentration of estradiol	Estradiol tested in peripheral blood	Change from the baseline of four weeks before major therapy at following-up
Secondary	Concentration of anti-mullerian hormone	Anti-mullerian hormone tested in peripheral blood	Change from the baseline of four weeks before major therapy at following-up
Secondary	Concentration of inhibin B	Inhibin B tested in peripheral blood	Change from the baseline of four weeks before major therapy at following-up
Secondary	Bladder capacity at the first void sense	Bladder capacity at the first void sense tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Bladder capacity at normal desire to void	Bladder capacity at normal desire to void tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Bladder capacity at strong desire to void	Bladder capacity at strong desire to void tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Maximun flow rate	Maximun flow rate tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Average flow rate	Average flow rate tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Bladder pressure at maximun flow rate	Bladder pressure at maximun flow rate tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Detrusor pressure at maximun flow rate	Detrusor pressure at maximun flow rate tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Bladder compliance at strong desire to void	Bladder compliance at strong desire to void tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Detrusor compliance at strong desire to void	Detrusor compliance at strong desire to void tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Residual urine volume	Residual urine volume tested by urodynamic testing	Change from the baseline of four weeks before major therapy at following-up
Secondary	Anal sphincter pressure	Anal sphincter pressure tested by rectum dynamic testing	Change from the baseline of four weeks before major therapy at following-up