Clinical trial NCT03967457: Comprehensive Study on the Quality of Life in Cervical Cancer Patients
Official title: Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Cervical Cancer
Urodynamics
Rectum Dynamics
Sex Dysfunction
Pelvic Floor Disorders
Ovarian Reserve Function
Survivorship
Disease-free Survival
Overall Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. They should be 18 years or older, accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study cente and achieving response after the major therapy.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Scores from EORTC QLQ-C30
timeFrame: 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.
measure: Scores from EORTC QLQ-CX24
timeFrame: 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 outcomes:
measure: Concentration of follicle-stimulating hormone
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Concentration of estradiol
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Concentration of anti-mullerian hormone
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Concentration of inhibin B
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Bladder capacity at the first void sense
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Bladder capacity at normal desire to void
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Bladder capacity at strong desire to void
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Maximun flow rate
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Average flow rate
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Bladder pressure at maximun flow rate
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Detrusor pressure at maximun flow rate
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Bladder compliance at strong desire to void
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Detrusor compliance at strong desire to void
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Residual urine volume
timeFrame: Change from the baseline of four weeks before major therapy at following-up
measure: Anal sphincter pressure
timeFrame: Change from the baseline of four weeks before major therapy at following-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: