MenopauseNCT00349011
Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer
A study testing Personalized risk assessment and genetic counseling intervention in people with Menopause, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Personalized risk assessment and genetic counseling intervention
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Mar 2004
- Phase
- Interventional
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least one first degree relative with breast cancer
- age 40 or older
Who cannot join
- currently taking a menopausal therapy
- previous cancer diagnosis (except basal cell carcinoma)
- previous diagnosis of atypical hyperplasia
- previous diagnosis of lobular carcinoma in situ (LCIS)
- known carrier of a BRCA1 or BRCA2 mutation
- personal history of heart disease
- >10% risk of carrying a BRCA1 or BRCA2 mutation
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?
The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.
Read the detailed description
Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.
- Conditions
- Menopause
- Being tested
- Personalized risk assessment, genetic counseling intervention
- Keywords
- menopause, genetic counseling, breast cancer, tamoxifen, chemoprevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized risk assessmentProcedure or surgery
genetic counseling interventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Knowledge of menopause and menopausal therapy
Satisfaction with counseling intervention
Medication usage
Secondary outcomes (2)
Perceived risk of breast cancer, heart disease, osteoporosis
Worry about breast cancer, heart disease, osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startAug 2002
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Women and Infants Hospital of Rhode Island, Stony Brook University
- Investigators
- Ellen T. Matloff, M.S., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349011
- Sponsor's protocol ID
- Komen BCTR0100202
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2006
- Last updated
- 30 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?
- ClinicalTrials.gov ID
- NCT00349011
- Acronym / sponsor ID
- Komen BCTR0100202
- Conditions
- Menopause
- Keywords
- menopause, genetic counseling, breast cancer, tamoxifen, chemoprevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Women and Infants Hospital of Rhode Island, Stony Brook University
- Study start
- Aug 2002
- Study completion
- Mar 2004
- First posted
- 6 Jul 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 purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.
Detailed description
Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least one first degree relative with breast cancer
- age 40 or older
Key exclusion criteria (7 listed)
- currently taking a menopausal therapy
- previous cancer diagnosis (except basal cell carcinoma)
- previous diagnosis of atypical hyperplasia
- previous diagnosis of lobular carcinoma in situ (LCIS)
- known carrier of a BRCA1 or BRCA2 mutation
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 |
|---|---|---|
| Personalized risk assessment | Procedure or surgery | – |
| genetic counseling intervention | Procedure or surgery | – |
Primary outcome
Decisional conflict
Knowledge of menopause and menopausal therapy
Satisfaction with counseling intervention
Medication usage
2 secondary outcomes
Perceived risk of breast cancer, heart disease, osteoporosis
Worry about breast cancer, heart disease, osteoporosis
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 30 Aug 2023.
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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.
Ellen T. Matloff, M.S. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized risk assessment and genetic counseling intervention in people with Menopause, run by Yale University 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 2 inclusion and 7 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 30 Aug 2023. 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?
Decisional conflict. The study lists 4 primary outcomes in all. 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 30 Aug 2023.