NCT03885505

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

November 25, 2018

Last Update Submit

June 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy

    through study completion, an average of half a year

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cervical cancer patients treated by radiotherapy

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of radiation oncology

Study Record Dates

First Submitted

November 25, 2018

First Posted

March 21, 2019

Study Start

June 25, 2019

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06