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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581646
First received: December 21, 2007
Last updated: January 31, 2014
Last verified: January 2014
  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. The researchers are interested in the participants' thoughts about these options and want to learn about the experiences of infertile women due to cancer treatment as well as women who are infertile due to other causes. The researchers hope that what they learn will allow them to better care for infertile women in the future.


Condition Intervention
Cervical Cancer
Endometrial Cancer
Leukemia
Non-Hodgkin's Lymphoma
Uterine Cancer
Vaginal Cancer
Infertility
Behavioral: survey instrument

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

Resource links provided by NLM:


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: gynecologic cancer survivors, survivors of hematological malignancies, & the non-cancer 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 non-cancer 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 non-cancer infertile women awaiting third party reproduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: September 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
gynecologic cancer survivors
Behavioral: survey instrument
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
2
survivors of any type of malignancy with history of BMT/SCT
Behavioral: survey instrument
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.
3
non-cancer infertile women awaiting third party reproduction
Behavioral: survey instrument
Participants will be mailed or given a one time survey instrument and data will be collected either in person or by telephone. We expect the study survey to take approximately 35-45 minutes to complete. The domains assessed will include psychological functioning, reproductive knowledge, perception of third party reproduction and concerns, sexual functioning, and quality of life.

Detailed Description:

As part of this study, you will be asked to fill out a series of questionnaires. These questions will 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 survivors and non-cancer infertile women

Criteria

Inclusion Criteria:

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

  • History of a primary diagnosis of gynecologic cancer or history of any primary 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 or 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 non-cancer 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
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: NCT00581646

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Investigators
Principal Investigator: Jeanne Carter, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581646     History of Changes
Other Study ID Numbers: 06-110
Study First Received: December 21, 2007
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Genital Diseases, Female
Genital Neoplasms, Female
Infertility
Lymphoma, Non-Hodgkin
Uterine Cervical Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Genital Diseases, Male
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on October 23, 2014