NCT00386217

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. 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. 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. 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. 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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

3.9 years

First QC Date

October 9, 2006

Last Update Submit

July 31, 2012

Conditions

Keywords

Cervical CancerBreast CancerHodgkin's DiseaseNon-Hodgkin's LymphomaFemale InfertilityTelephone Survey

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

Behavioral: Telephone Survey

Interventions

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

Also known as: Questionnaire
Telephone Survey

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseUterine Cervical NeoplasmsBreast NeoplasmsLymphomaLymphoma, Non-HodgkinInfertility, Female

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesInfertility

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Leslie R. Schover, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations