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

NCT00581646 | Completed

• 1 other identifier: 06-110
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Study Arms (3)

1

gynecologic cancer survivors

Behavioral: survey instrument

2

survivors of any type of malignancy with history of BMT/SCT

Behavioral: survey instrument

3

non-cancer infertile women awaiting third party reproduction

Behavioral: survey instrument

Interventions

survey instrument 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.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• New York Presbyterian Hospital: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Leukemia; Lymphoma, Non-Hodgkin; Uterine Neoplasms; Vaginal Neoplasms; Infertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jeanne Carter, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (1)