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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03885505
Other study ID # ZHN 20181125
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 25, 2019
Est. completion date September 1, 2019

Study information

Verified date June 2019
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date September 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary using fact-cx4.0 to evaluate the qol of cervical cancer patients undergoing radiotherapy 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 using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy 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
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