Hodgkin's DiseaseNCT00386217
Psychosocial Impact of Cancer-Related Female Infertility
An observational study of Hodgkin's Disease and Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Hodgkin's Disease, Cervical Cancer, Breast Cancer
- What is being tested?
- Telephone Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Women's fluency in English must be adequate to complete the interview (approximately 6th grade level).
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
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:
- 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
- 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
- To refine the psychometric properties of questionnaires for female cancer survivors measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards Parenthood after Cancer
- 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.
Read the 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.
- Conditions
- Hodgkin's Disease, Cervical Cancer, Breast Cancer, Lymphoma
- Being tested
- Telephone Survey
- Keywords
- Cervical Cancer, Breast Cancer, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Female Infertility, Telephone Survey
- Medical subject headings
- Hodgkin Disease, Uterine Cervical Neoplasms, Breast Neoplasms, Lymphoma, Lymphoma, Non-Hodgkin, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone SurveyBehavioural
Also called Questionnaire
Telephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Survey | 90 minute Telephone survey of female cancer survivors Receives: Behavioral: Telephone Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Impact of Cancer Treatment on Childbearing: Female Cancer Survivor Response to Telephone Survey
Measured: Single telphone survey lasting about 90 minutes, 4 Years to collect complete surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startDec 2004
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leslie R. Schover, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386217
- Sponsor's protocol ID
- 2003-0568
- Status last verified
- Jul 2012
- First submitted
- 9 Oct 2006
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Impact of Cancer-Related Female Infertility
- ClinicalTrials.gov ID
- NCT00386217
- Acronym / sponsor ID
- 2003-0568
- Conditions
- Hodgkin's Disease, Cervical Cancer, Breast Cancer, Lymphoma
- Keywords
- Cervical Cancer, Breast Cancer, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Female Infertility, Telephone Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- To refine the psychometric properties of questionnaires for female cancer survivors measuring Distress about Cancer-Related Childbearing Issues and Attitudes towards Parenthood after Cancer
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telephone Survey | – | Behavioral: Telephone Survey90 minute Telephone survey of female cancer survivors |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Women's fluency in English must be adequate to complete the interview (approximately 6th grade level).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone SurveyAlso: QuestionnaireTelephone interview, about 90 minutes, covering demographic information, medical information, health-related quality of life, emotional distress, and stress related to interrupted childbearing. | Behavioural | Telephone Survey |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie R. Schover, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Disease and Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.