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Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, September 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581646
  Purpose

This study aims to learn about the needs and feelings of women who are infertile. Being infertile means not being able to have a child without the help of a third party. There are other options for building a family. We are interested in your thoughts about these options. We want to learn about the experiences of women infertile due to cancer treatment as well as women who are infertile due to other causes. We hope what we learn will allow us to better care for infertile women in the future.


Condition
Cervical Cancer
Endometrial Cancer
Leukemia
Non-Hodgkin's Lymphoma
Uterine Cancer
Vaginal Cancer

MedlinePlus related topics:   Cancer    Cervical Cancer    Infertility    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Uterine Cancer    Vaginal Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Investigate emotional, sexual functioning, reproductive concerns and qol experience of 3 groups of infertile women:gyn cancer survivors, survivors of hematological malig, & the noncancer infertile women awaiting 3rd party reproduction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess and describe the attitudes towards, knowledge of and utilization of third party reproduction of the study participants' (cancer and noncancer infertile groups). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Compare the main domains of depression, distress, sexual functioning and overall qol of the gynecologic cancer survivors and survivors of a hematological malignancy with history of BMT/SCT to noncancer infertile women awaiting third party reproduction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   120
Study Start Date:   September 2006
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
gyn cancer survivors
2
survivors of any type of malignancy with history of BMT/SCT
3
noncancer infertile women awaiting third party reproduction

Detailed Description:

As part of this study, you will be asked to fill out a series of questionnaires. These questions ask about your feelings, sexual function, quality of life, and ideas about reproductive options. We will also ask some questions about you, your health, and your medical history. You can choose to answer these questions either at one of your doctor visits or over the telephone. You can decide the best way to complete this assessment.

  Eligibility
Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Cervical cancer Endometrial cancer Leukemia Non-Hodgkin's Lymphoma Uterine cancer Vaginal cancer


Criteria

Inclusion Criteria:

Study group of Gynecologic cancer survivors and BMT/SMT cancer survivors:

  • History of a primary diagnosis of gynecologic cancer or History primary of any malignancy treated with BMT/SCT- No evidence of disease for at least one year
  • At least 18 years of age not greater than 49 years of age at time of study recruitment
  • No other cancer history
  • Have impaired fertility:
  • Lack of uterus but intact ovaries
  • Lack of ovaries or lack of ovarian function based on the FSH determination but intact uterus
  • Have not started or have not completed childbearing
  • Able and willing to provide informed consent
  • Ability to comprehend and complete questionnaire in English

Comparison Group of noncancer infertile women awaiting egg (oocyte)donation:

  • No cancer history
  • At least 18 years of age not greater than 49 years of age at time of study recruitment
  • In ovarian failure and on a waiting list for egg (oocyte) donation
  • Have not started or have not completed childbearing
  • Able and willing to provide informed consent
  • Ability to comprehend and complete questionnaire in English

Exclusion Criteria:

  • Inability to participate in an informed consent process
  • Patients with a psychiatric disorder precluding response to the survey
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581646

Contacts
Contact: Jeanne Carter, PhD     carterj@mskcc.org    

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center     Recruiting
      New York, New York, United States, 10021
      Contact: Jeanne Carter, PhD         carterj@mskcc.org    

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
  More Information


Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Jeanne Carter, Ph.D )
Study ID Numbers:   06-110
First Received:   December 21, 2007
Last Updated:   September 5, 2008
ClinicalTrials.gov Identifier:   NCT00581646
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Vaginal Neoplasms
Infertility
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Genital Neoplasms, Female
Vaginal cancer
Uterine Diseases
Vaginal Diseases
Urogenital Neoplasms
Genital Diseases, Male
Uterine Cervical Neoplasms
Genital Diseases, Female
Lymphatic Diseases
Leukemia
Endometrial Neoplasms
Uterine Cervical Diseases
Uterine Neoplasms
Endometrial cancer
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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