Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients

Stem Cell Transplantation Clinical Trial

Official title:

Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among Young Women Who Underwent Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429455
• Other study ID #: 2005-0997
• Status: Completed
• Phase: N/A
• First received: January 29, 2007
• Last updated: July 31, 2012
• Start date: March 2007
• Est. completion date: August 2009

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.

• Age 16 to 50 years at the time of the transplant.

Exclusion Criteria:

• History of ovarian cancer.

• History of hysterectomy/oophorectomy

• Non-English speaking patients

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Stem Cell Transplantation

Intervention

Behavioral:
• Survey
3-Part Questionnaire

Locations

Country	Name	City	State
United States	U.T. M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Survey Responders		2 Years	No

External Links

•   UT MD Anderson Cancer Center