- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01589406
Quality of Life and Sexuality in Women With Gynaecological Cancer
May 1, 2012 updated by: Rambam Health Care Campus
Patients with premalignant (CIN3) and malignant cervical cancer will asked to complete questionnaires regarding intimacy (ENRICH) and life adaptation (PAIS) before treatment (surgery or radiotherapy) and after completion of treatment in order to estimate the influence of disease and treatment on quality of life indices.
Study Overview
Status
Unknown
Conditions
Detailed Description
no additional information.
see above
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Haifa, Israel
- Rambam Medical Center
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
women with Gynaecological cancer
Description
Inclusion Criteria:
- women with Gynaecological cancer intended to undergo chemotherapy or surgery
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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group A group B
A:Patients for surgical intervention B:Patients for radiotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: 2 years
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longitudinal describtion of quality of life during treatment
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: amnon amit, md, Rambam Health Care Campus
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
June 1, 2012
Primary Completion (Anticipated)
May 1, 2014
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
April 29, 2012
First Submitted That Met QC Criteria
May 1, 2012
First Posted (Estimate)
May 2, 2012
Study Record Updates
Last Update Posted (Estimate)
May 2, 2012
Last Update Submitted That Met QC Criteria
May 1, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 538-10CTIL
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.