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

Completed

• Conditions: Cervical Cancer; Leukemia; Endometrial Cancer; Non-Hodgkin's Lymphoma; Uterine Cancer; Vaginal Cancer; Infertility
• Interventions: Behavioral: survey instrument

• Registration Number: NCT00581646
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-28
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	survey instrument	non-cancer infertile women awaiting third party reproduction
2	survey instrument	survivors of any type of malignancy with history of BMT/SCT
1	survey instrument	gynecologic cancer survivors

Primary Outcome Measures

Name	Time	Method
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	2 years

Secondary Outcome Measures

Name	Time	Method
Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)	2 years
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	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States