Cervical CancerNCT03885505
An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
An observational study of Cervical Cancer and Radiotherapy Side Effect, run by Peking Union Medical College Hospital.
Trial summary
Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Radiotherapy Side Effect, Quality of Life
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cervical cancer patients treated by radiotherapy
Who may be able to join
- 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
Who cannot join
- with cognitive dysfunction or cannot fulfilled the questionaire
- refuse or quit the research
- submit questionnaire with missing information
About this study
Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life
Read the 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
- Conditions
- Cervical Cancer, Radiotherapy Side Effect, Quality of Life
- Medical subject headings
- Uterine Cervical Neoplasms, Radiation Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of half a year
Secondary outcomes (1)
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.
Measured: through study completion, an average of half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Jun 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HONGNAN ZHEN, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885505
- Sponsor's protocol ID
- ZHN 20181125
- Status last verified
- Jun 2019
- First submitted
- 25 Nov 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
- ClinicalTrials.gov ID
- NCT03885505
- Acronym / sponsor ID
- ZHN 20181125
- Conditions
- Cervical Cancer, Radiotherapy Side Effect, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Jun 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical cancer radiotherapy patients have a decline in quality of life and sexual 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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cervical cancer patients treated by radiotherapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- with cognitive dysfunction or cannot fulfilled the questionaire
- refuse or quit the research
- submit questionnaire with missing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy
Time frame: through study completion, an average of half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Radiotherapy Side Effect, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.