Psychosocial Impact of Cancer-Related Female Infertility

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00386217
First received: October 9, 2006
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

The success of cancer treatment combined with the trend to delay childbearing is increasing the numbers of women survivors whose childbearing has been interrupted by cancer. For some, treatment has resulted in infertility. Others have been advised to delay pregnancy until a certain follow-up interval or have new fears that pregnancy could be a risk to maternal health. Not least is the concern that children born after a mother's cancer would face increased risks for birth defects or cancer.

The specific aims of this project are as follows:

  1. To measure the impact of cancer-related interruption of childbearing on women's long-term emotional well-being and health-related quality of life, over and above other demographic and cancer-related factors
  2. To find out if becoming a biological or social mother after cancer treatment decreases the long-term psychosocial impact of interrupted childbearing compared to remaining childless
  3. To refine the psychometric properties of questionnaires for female cancer survivors measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards Parenthood after Cancer
  4. To define targets for a future intervention to improve female survivors' knowledge about childbearing after cancer, decrease distress associated with interrupted childbearing, and promote peer support.

Condition Intervention
Hodgkin's Disease
Cervical Cancer
Breast Cancer
Lymphoma
Behavioral: Telephone Survey

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Impact of Cancer-Related Female Infertility

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Emotional Impact of Cancer Treatment on Childbearing: Female Cancer Survivor Response to Telephone Survey [ Time Frame: Single telphone survey lasting about 90 minutes, 4 Years to collect complete surveys ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: December 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Telephone Survey
90 minute Telephone survey of female cancer survivors
Behavioral: Telephone Survey
Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.
Other Name: Questionnaire

Detailed Description:

Women from the M. D. Anderson tumor registry who were diagnosed from 1992 to 1997 with invasive cervical cancer, breast cancer, Hodgkin's disease, or non-Hodgkin's lymphoma will be asked to participate. Researchers have chosen these types of cancers because they are the most common cancers in women of reproductive age. In addition, many of the standard treatments for these diseases have the potential to cause infertility.

If you agree to participate, you will be asked to complete a survey over the phone. Topics that will be addressed by the survey include demographic information (such as age, sex, etc.), medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing. Some other topics include anxiety related to the impact of cancer on childbearing, menopausal symptoms, spiritual well-being, relationship happiness, sexual satisfaction, and attitudes about parenthood after cancer. The phone survey should take around 90 minutes to complete.

If you feel distressed at any time during or after your participation in this study, you will be given a referral for professional counseling.

THIS IS AN INVESTIGATIONAL STUDY.

Up to 2091 women will be invited to participate in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female survivors of breast cancer, cervical cancer, Hodgkin's Disease, or non-Hodgkin's lymphoma, age 14 years and older, who were diagnosed before the age of 41 during the period of 1993-1998.

Criteria

Inclusion Criteria:

  1. Women must be survivors of breast cancer, cervical cancer, Hodgkin's Disease, or non-Hodgkin's lymphoma. (We have chosen these three sites because they are the most common malignancies in women of reproductive age that have reasonable rates of long-term survival. In addition, many of the standard treatments for these malignancies impair fertility.)
  2. Women must have been diagnosed before the age of 41, i.e., of childbearing age at the time of diagnosis and/or beyond.
  3. Women must be at least age 14 currently to participate, because of the concern that younger girls may not be emotionally mature enough to have considered the emotional aspects of infertility, and may also not have full knowledge about reproduction.
  4. Women must must have been diagnosed between the years of 1993-1998, making them, roughly 5- to 10-year survivors.
  5. We are not going to exclude women based on cancer stage or treatment status, as long as they have survived for 5 to 10 years.

Exclusion Criteria:

1. Women's fluency in English must be adequate to complete the interview (approximately 6th grade level).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386217

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Leslie R. Schover, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00386217     History of Changes
Other Study ID Numbers: 2003-0568
Study First Received: October 9, 2006
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Breast Cancer
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Female Infertility
Telephone Survey

Additional relevant MeSH terms:
Lymphoma
Breast Neoplasms
Infertility
Uterine Cervical Neoplasms
Hodgkin Disease
Infertility, Female
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on September 18, 2014