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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885505
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
HONGNAN ZHEN, Peking Union Medical College Hospital

Brief Summary:
Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life

Condition or disease
Cervical Cancer Radiotherapy Side Effect Quality of Life

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
Estimated Study Start Date : June 25, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cervical cancer patients treated by radiotherapy
Criteria

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
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Responsible Party: HONGNAN ZHEN, department of radiation oncology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03885505    
Other Study ID Numbers: ZHN 20181125
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female