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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429455
First received: January 29, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

Primary Objective:

- 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: Survey

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among Young Women Who Underwent Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Survey Responders [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: March 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Survey Participants
Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.
Behavioral: Survey
3-Part Questionnaire

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429455     History of Changes
Other Study ID Numbers: 2005-0997
Study First Received: January 29, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Fertility
Menopause
Hematopoietic Stem Cell Transplantation
Questionnaire
Survey

ClinicalTrials.gov processed this record on July 23, 2014