Comprehensive Study on the Quality of Life in Cervical Cancer Patients

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: questionnaires survey
* Diagnostic Test: Urodynamic testing
* Diagnostic Test: Rectum dynamics testing
* Diagnostic Test: ovarian reserve function


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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)|
|Diagnostic Test: 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|
|Diagnostic Test: Rectum dynamics testing|Rectum dynamics testing consists of important parameters of rectum activities|
|Diagnostic Test: ovarian reserve function|Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Concentration of estradiol | Estradiol tested in peripheral blood | Change from the baseline of four weeks before major therapy at following-up | 
| 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 | 
| Concentration of inhibin B | Inhibin B tested in peripheral blood | Change from the baseline of four weeks before major therapy at following-up | 
| 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 | 
| 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 | 
| 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 | 
| Maximun flow rate | Maximun flow rate tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up | 
| Average flow rate | Average flow rate tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Residual urine volume | Residual urine volume tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up | 
| Anal sphincter pressure | Anal sphincter pressure tested by rectum dynamic testing | Change from the baseline of four weeks before major therapy at following-up |