Psychosocial Impact of Cancer-Related Female Infertility
1 other identifier
observational
239
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 9, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 1, 2012
July 1, 2012
3.9 years
October 9, 2006
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Emotional Impact of Cancer Treatment on Childbearing: Female Cancer Survivor Response to Telephone Survey
Single telphone survey lasting about 90 minutes, 4 Years to collect complete surveys
Study Arms (1)
Telephone Survey
90 minute Telephone survey of female cancer survivors
Interventions
Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- \. Women's fluency in English must be adequate to complete the interview (approximately 6th grade level).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie R. Schover, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2006
First Posted
October 11, 2006
Study Start
December 1, 2004
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
August 1, 2012
Record last verified: 2012-07