Quality of Life Clinical Trial
Official title:
Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study
NCT number | NCT03967457 |
Other study ID # | CCQOL |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 19, 2019 |
Est. completion date | June 1, 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
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 |
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