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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	New York Presbyterian Hospital
Information provided by (Responsible Party):	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. 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:

MedlinePlus related topics: Cancer Cervical Cancer Infertility Leukemia Lymphoma Uterine Cancer Vaginal Cancer

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2012 (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

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:

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

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 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Endometrial Neoplasms
Uterine Cervical Neoplasms
Infertility
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Uterine Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Genital Diseases, Male
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vaginal Diseases

ClinicalTrials.gov processed this record on February 12, 2012