Quality of Life and Sexuality in Women With Gynaecological Cancer
This study is not yet open for participant recruitment.
Verified April 2012 by Rambam Health Care Campus
Sponsor:
Rambam Health Care Campus
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01589406
First received: April 29, 2012
Last updated: May 1, 2012
Last verified: April 2012
| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2012 | ||||
| Last Updated Date | May 1, 2012 | ||||
| Start Date ICMJE | June 2012 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ] longitudinal describtion of quality of life during treatment |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01589406 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life and Sexuality in Women With Gynaecological Cancer | ||||
| Official Title ICMJE | Quality of Life and Sexuality in Women With Gynaecological Cancer | ||||
| Brief Summary | 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. |
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| Detailed Description | no additional information. see above |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | women with Gynaecological cancer |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | group A group B
A:Patients for surgical intervention B:Patients for radiotherapy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | May 2014 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01589406 | ||||
| Other Study ID Numbers ICMJE | 538-10CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rambam Health Care Campus | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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