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

Purpose

Primary Objective:

1. To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation.

Condition	Intervention
Stem Cell Transplantation	Behavioral: Questionnaire

MedlinePlus related topics:

Menopause

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	640
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.	Behavioral: Questionnaire 3-Part Questionnaire

Detailed Description:

We 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. We 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, we would like to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to tell us what kind of information they got and would like to have gotten before or during their treatment.

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429455

Contacts


Contact: Naoto Ueno, MD, PhD	713-792-8754

Locations


United States, Texas
	U.T. M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Naoto Ueno, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Naoto Ueno, MD, PhD	U.T. M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Naoto Ueno, MD, PhD/Associate Professor )
Study ID Numbers:	2005-0997
First Received:	January 29, 2007
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00429455
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Fertility

Menopause

Hematopoietic Stem Cell Transplantation

Questionnaire

Survey

Study placed in the following topic categories:

Menopause

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00429455