Clinical trial NCT00581646: Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
Official title: Cross-Sectional Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Endometrial Cancer
Leukemia
Non-Hodgkin's Lymphoma
Uterine Cancer
Vaginal Cancer
Infertility
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2007-12-28
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Assess and describe the attitudes towards, knowledge of, and utilization of third party reproduction of the study participants (cancer and non-cancer infertile groups)
timeFrame: 2 years
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jeanne Carter, PhD
role: PRINCIPAL_INVESTIGATOR
References: