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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00581646
Collaborator
New York Presbyterian Hospital (Other)
179
1
105
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: survey instrument

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 Design

Study Type:
Observational
Actual Enrollment :
179 participants
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
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • New York Presbyterian Hospital

Investigators

  • Principal Investigator: Jeanne Carter, PhD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00581646
Other Study ID Numbers:
  • 06-110
First Posted:
Dec 28, 2007
Last Update Posted:
Jul 8, 2015
Last Verified:
Jul 1, 2015

Study Results

No Results Posted as of Jul 8, 2015