Breast CancerNCT00588705
The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
An observational study of Breast Cancer and Counseling, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Counseling
- What is being tested?
- focus group & questionaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2017
- 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 12 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical genetics service (CGS)and their daughters
Who may be able to join
- Women seen in the MSK CGS Service who have a diagnosis of breast cancer or
- a family history of breast cancer and
- have biological daughter(s) in the age range 12-20 years will be eligible to participate in Phase I \& II.
- Women who were consented to Phase I will automatically be eligible for Phase II.
Who cannot join
- Women seen in the MSK CGS Service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer,
- do not have a biological daughter,
- or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to Phase 1).
- Women will be ineligible if they are not English speaking,
- have intellectual or cognitive impairment,
- or active mental illness rendering them incapable of giving informed consent, such as might occur with active psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters.
A second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks.
All of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.
- Conditions
- Breast Cancer, Counseling
- Being tested
- focus group & questionaire
- Keywords
- Daughters, Communication, genetic risk, Genetic Counseling
- Medical subject headings
- Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus group & questionaireBehavioural
The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.
| Study group | Role | What they receive |
|---|---|---|
| focus group & questionaire | The group will discuss its views about how and when to talk about the risk of getting breast cancer. The focus group will be video recorded and the video recorded material will be later transcribed and carefully analyzed. In addition you will be asked to answer questions about yourself, such as education and marital status. Receives: Behavioral: focus group & questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module.
Measured: conclusion of study
Secondary outcomes (1)
To examine the views of women about the provision of genetic risk information to their daughters.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Smita Banerjee, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588705
- Sponsor's protocol ID
- 07-063
- Status last verified
- Jan 2017
- First submitted
- 24 Dec 2007
- Last updated
- 30 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00588705
- Acronym / sponsor ID
- 07-063
- Conditions
- Breast Cancer, Counseling
- Keywords
- Daughters, Communication, genetic risk, Genetic Counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- Dec 2007
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Jan 2008 (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 first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters.
A second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks.
All of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| focus group & questionaire | – | Behavioral: focus group & questionaireThe group will discuss its views about how and when to talk about the risk of getting breast cancer. The focus group will be video recorded and the video recorded material will be later transcribed and carefully analyzed. In addition you will be asked to answer questions about yourself, such as education and marital status. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical genetics service (CGS)and their daughters
Key inclusion criteria (4 listed)
- Women seen in the MSK CGS Service who have a diagnosis of breast cancer or
- a family history of breast cancer and
- have biological daughter(s) in the age range 12-20 years will be eligible to participate in Phase I \& II.
- Women who were consented to Phase I will automatically be eligible for Phase II.
Key exclusion criteria (6 listed)
- Women seen in the MSK CGS Service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer,
- do not have a biological daughter,
- or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to Phase 1).
- Women will be ineligible if they are not English speaking,
- have intellectual or cognitive impairment,
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 |
|---|---|---|
| focus group & questionaireThe focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes. | Behavioural | focus group & questionaire |
Primary outcome
Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module.
Time frame: conclusion of study
1 secondary outcome
To examine the views of women about the provision of genetic risk information to their daughters.
Time frame: conclusion of study
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 Jan 2017.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Smita Banerjee, PhD principal investigator
Memorial Sloan Kettering 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 Breast Cancer and Counseling, run by Memorial Sloan Kettering 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 4 inclusion and 6 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 Jan 2017. 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?
Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module. (time frame: conclusion of study). 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 Jan 2017.