An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients

June 22, 2019 updated by: HONGNAN ZHEN, Peking Union Medical College Hospital
Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life

Study Overview

Status

Unknown

Conditions

Detailed Description

Objective: To investigate the quality of life and sexual quality of life and its influencing factors in cervical cancer undergoing radiotherapy patients.

Methods:The cervical cancer cancer scale (FACT-Cx4.0) and the female sexual function index (FSFI) in the cancer treatment function evaluation system were used. The quality of life and sexual quality of life of cervical cancer patients undergoing radiotherapy in PUMC Hospital were analyzed and scored to analyze the effects of age, education level, clinical stage and treatment methods on the quality of life and sexual quality of life of cervical cancer radiotherapy patients

Study Type

Observational

Enrollment (Anticipated)

200

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Cervical cancer patients treated by radiotherapy

Description

Inclusion Criteria:

  • adult female
  • diagnosed with cervical cancer' and acquire therapy as part of treatment
  • undertaken or have finished radiotherapy in Peking Union Medical College Hospital
  • agreed with informed consent

Exclusion Criteria:

  • with cognitive dysfunction or cannot fulfilled the questionaire
  • refuse or quit the research
  • submit questionnaire with missing information

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
using fact-cx4.0 to evaluate the qol of cervical cancer patients undergoing radiotherapy
Time Frame: through study completion, an average of half a year

Functional Assessment of Cancer Therapy-Cervix V4.0 (FACT-Cx V4.0) was used to evaluate patients'quality of life. The scale is composed of general cancer quality of life assessment scale (FACT-G) and cervical cancer specific module (CCS). It contains 5 dimensions and 42 subjects. The higher the score of positive questions, the better the quality of life. The higher the score of reverse questions, the worse the quality of life. If it is a reverse question, the original score of this question is subtracted by 4. The higher the total score, the better the quality of life. The study was conducted by face-to-face investigation of specialist nurses. All patients'investigation data were kept strictly confidential.

And follow the principles of medical ethics.using spss to analysis the data.
through study completion, an average of half a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy
Time Frame: through study completion, an average of half a year
Female Sexual Function Index (FSFI) was used to measure the quality of sexual life. The higher the score of positive items, the worse the quality of sexual life. If the reverse items were negative, the original score of the item could be subtracted by 5. The higher the total score, the better the quality of sexual life. The study was conducted by face-to-face investigation by specialist nurses. All patients'investigation data were strictly confidential and followed the medical ethics principles.using spss to analysis the data.
through study completion, an average of half a year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (Anticipated)

June 25, 2019

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 22, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZHN 20181125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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