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

NCT ID: NCT00581646

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

gynecologic cancer survivors

survey instrument

Intervention Type: BEHAVIORAL

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

survey instrument

Intervention Type: BEHAVIORAL

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

survey instrument

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanne Carter, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

06-110

Identifier Type: -

Identifier Source: org_study_id