Comprehensive Study on the Quality of Life in Cervical Cancer Patients

June 19, 2019 updated by: Lei Li

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores from EORTC QLQ-C30
Time Frame: 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 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
Time Frame: 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 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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Follicle-stimulating hormone tested in peripheral blood
Change from the baseline of four weeks before major therapy at following-up
Concentration of estradiol
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Estradiol tested in peripheral blood
Change from the baseline of four weeks before major therapy at following-up
Concentration of anti-mullerian hormone
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Anti-mullerian hormone tested in peripheral blood
Change from the baseline of four weeks before major therapy at following-up
Concentration of inhibin B
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Maximun flow rate tested by urodynamic testing
Change from the baseline of four weeks before major therapy at following-up
Average flow rate
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
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
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Residual urine volume tested by urodynamic testing
Change from the baseline of four weeks before major therapy at following-up
Anal sphincter pressure
Time Frame: Change from the baseline of four weeks before major therapy at following-up
Anal sphincter pressure tested by rectum dynamic testing
Change from the baseline of four weeks before major therapy at following-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCQOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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