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Completed

NCT Number: NCT00386217

Psychosocial Impact of Cancer-Related Female Infertility

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • Women must have been diagnosed before the age of 41, i.e., of childbearing age at the time of diagnosis and/or beyond.
  • 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.
  • Women must must have been diagnosed between the years of 1993-1998, making them, roughly 5- to 10-year survivors.
  • 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

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

Treatment and study plan

Telephone Survey

Behavioral

Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.

Other names: Questionnaire

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 11, 2006
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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