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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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