Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients
| Tracking Information | |||||
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| First Received Date ICMJE | January 29, 2007 | ||||
| Last Updated Date | July 31, 2012 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of Survey Responders [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00429455 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 | Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients | ||||
| Official Title ICMJE | Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among Young Women Who Underwent Hematopoietic Stem Cell Transplantation | ||||
| Brief Summary | Primary Objective: - To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation. |
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| Detailed Description | Researchers are currently conducting a survey on how important it is to women who are having a stem cell transplant to have information about the effects of the treatment on their fertility (their ability to have children) and on the risk of early menopause. Researchers know that some women who had transplants think that the information that they received may have been lacking or was not appropriate for their needs. Therefore, researchers would like to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to report what kind of information they got and would like to have gotten before or during their treatment. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center. |
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| Condition ICMJE | Stem Cell Transplantation | ||||
| Intervention ICMJE | Behavioral: Survey
3-Part Questionnaire |
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| Study Group/Cohort (s) | Survey Participants
Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.
Intervention: Behavioral: Survey |
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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 | Completed | ||||
| Enrollment ICMJE | 196 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 16 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00429455 | ||||
| Other Study ID Numbers ICMJE | 2005-0997 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 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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