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Psychosocial Impact of Cancer-Related Female Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386217
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : August 1, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment
Hodgkin's Disease Cervical Cancer Breast Cancer Lymphoma Behavioral: Telephone Survey

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.


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

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Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Impact of Cancer-Related Female Infertility
Study Start Date : December 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes 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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386217

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United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Leslie R. Schover, PhD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00386217    
Other Study ID Numbers: 2003-0568
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012
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:
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Uterine Cervical Neoplasms
Hodgkin Disease
Infertility, Female
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Genital Diseases, Male