Trial record 7 of 1164 for:
infertility
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
This study is ongoing, but not recruiting participants.
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
First received: December 21, 2007
Last updated: January 31, 2013
Last verified: January 2013
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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:
Benign Tumors
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 2013 |
| Estimated Primary Completion Date: | December 2013 (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:
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, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Infertility Endometrial Neoplasms Uterine Cervical Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Uterine Neoplasms Vaginal Neoplasms Adenoma 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 Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 16, 2013