Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00858078
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2009-03-06
Brief Title:
A Qualitative Exploration of the Impact of Positive BRCA12 Mutation Status on the Lives of Young Women
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Qualitative Exploration of the Impact of Positive BRCA 12 Mutation Status on the Lives of Young Women
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer as high as 90 and 60 respectively as well as accompanying risks for several other types of cancer Women who have these genetic anomalies and who do not have cancer are aware of their high-risk status which can have an effect on their ability to make decisions about personal choices and health care
Researchers are interested in learning more about how people who know their cancer risk status make decisions on personal relationships family formation and risk-reduction options
Objectives
- To study young women s experiences and decision-making processes regarding family history genetic testing couple relationships family formation and cancer risk management within the context of their experiences as BRCA12 mutation carriers
Eligibility
Women between the ages of 18 and 35 years of age and older who have been identified as having a BRCA1 or BRCA2 mutation Participants must be contemplating or have experienced couple relationships family formation andor risk management and reduction
Participants must be willing to have their interviews digitally recorded
Design
Researchers will conduct between 30 and 50 telephone interviews of study participants Each interview will be approximately 90 minutes in length The interview consists of open-ended questions that ask about the participants and their experiences before during and after they underwent genetic testing for BRCA12
At least one focus group will be coordinated at a national conference for individuals who are aware of their genetically based cancer risk If more than 25 individuals are interested in participating in the group an additional focus group will be convened
No medical treatments are specifically offered as a part of this study
Mutations detected in the BRCA1 or BRCA2 genes have been show to produce very high risks of breast and ovarian cancer as high as 90 and 60 respectively as well as accompanying risks for several other types of cancer Women who have these genetic anomalies and who do not have cancer are aware of their high-risk status which can have an effect on their ability to make decisions about personal choices and health care
Researchers are interested in learning more about how people who know their cancer risk status make decisions on personal relationships family formation and risk-reduction options
Objectives
- To study young women s experiences and decision-making processes regarding family history genetic testing couple relationships family formation and cancer risk management within the context of their experiences as BRCA12 mutation carriers
Eligibility
Women between the ages of 18 and 35 years of age and older who have been identified as having a BRCA1 or BRCA2 mutation Participants must be contemplating or have experienced couple relationships family formation andor risk management and reduction
Participants must be willing to have their interviews digitally recorded
Design
Researchers will conduct between 30 and 50 telephone interviews of study participants Each interview will be approximately 90 minutes in length The interview consists of open-ended questions that ask about the participants and their experiences before during and after they underwent genetic testing for BRCA12
At least one focus group will be coordinated at a national conference for individuals who are aware of their genetically based cancer risk If more than 25 individuals are interested in participating in the group an additional focus group will be convened
No medical treatments are specifically offered as a part of this study
Detailed Description:
Background
BRCA12 mutations are present in approximately 1 in 800 individuals in the US with higher frequency among some populations eg Ashkenazi Jews
Mutations confer a lifetime breast cancer risk approaching 90 ovarian cancer risk as high as 60 and lesser increases in absolute risks of selected other cancers eg male breast prostate pancreas
We have successfully conducted follow-up interviews with women in our original studies who had known about their mutations for less than six months and have gleaned useful longitudinal data We now propose to conduct additional follow-up interviews with participants who were in the process of making significant decisions about risk-management relationships family formation and other pertinent issues at the time of their initial interviews
Additionally previous research indicates that women who undergo genetic testing very early in young adulthood ie prior to their 25th birthdays have genetic counseling and support needs that are different from the broader BRCA-positive population
Research regarding how these very young mutation carriers manage and accommodate their risk is scarce We propose to conduct two focus groups with women who considered andor underwent genetic testing for BRCA prior to their 25th birthdays who are attending the Joining FORCES annual conference in Orlando FL June 23-25 2011
The Study Application has been updated with this amendment to reflect the following changes 1 the inclusion of males who may be enrolled only in the Family Group Interview component of the study 2 the inclusion older individuals as some women may wish to include male or older members of their family in Family Group Interview portion of the study To reflect this change the maximum age for study participants has been increased to 100 years of age and males are no longer listed as excluded from the study
Objectives
For follow-up to previous study
-- Conduct follow-up telephone interviews with participants who were newly-tested at the time of original data collection to increase understanding of their mutation-positive experience longitudinally
For 25 Under study
Conduct two 2 focus group sessions at the Joining FORCES Annual Conference focusing on the unique genetic counseling and support needs of women who consider or undergo genetic testing for BRCA12 prior to age 25
Eligibility
For follow-up to previous study
-- Individuals who were in the process of making decisions relative to their status as mutation positive at the time of their previous interviews will be re-interviewed in order to learn about their longitudinal experiences and expand the data set
For 25 Under study
Women aged 18-24 who have received a positive BRCA12 mutation test result
Women aged 25-30 who considered or completed genetic testing for BRCA12 prior to their 25th birthdays
English-speaking
Attending the 2011 Joining FORCES Annual Conference
Design
For follow-up to previous study
Individuals will be invited to participate in a second telephone interview during which they will be asked to describe their mutation-related experience since their previous interviews approximately two years ago
Questions for each participant will be specifically tailored based on their previous interview data Telephone interviews are anticipated to be approximately 60 minutes in length
Note In cases where an individual eligible for follow-up is also participating in the multi-generational family interview see Amendment A the individual interview conducted as part of that study will take the place of a follow-up telephone interview
For 25 Under Study
Individuals who meet eligibility criteria will be invited to participate in either of two focus group sessions being held during the FORCE conference
Following the conference each participant will be contacted via telephone to complete a brief family history interview in order to provide context for the data collected during the focus group
Focus groups will be conducted using a prepared guide see attachment
Participants will be entered into a raffle at each session and one participant in each session will win a 50 gift card
Focus group sessions and telephone family history interviews will be audio recorded then they will be transcribed and analyzed using modified grounded theoretical design and QSR NVivo v8 software
BRCA12 mutations are present in approximately 1 in 800 individuals in the US with higher frequency among some populations eg Ashkenazi Jews
Mutations confer a lifetime breast cancer risk approaching 90 ovarian cancer risk as high as 60 and lesser increases in absolute risks of selected other cancers eg male breast prostate pancreas
We have successfully conducted follow-up interviews with women in our original studies who had known about their mutations for less than six months and have gleaned useful longitudinal data We now propose to conduct additional follow-up interviews with participants who were in the process of making significant decisions about risk-management relationships family formation and other pertinent issues at the time of their initial interviews
Additionally previous research indicates that women who undergo genetic testing very early in young adulthood ie prior to their 25th birthdays have genetic counseling and support needs that are different from the broader BRCA-positive population
Research regarding how these very young mutation carriers manage and accommodate their risk is scarce We propose to conduct two focus groups with women who considered andor underwent genetic testing for BRCA prior to their 25th birthdays who are attending the Joining FORCES annual conference in Orlando FL June 23-25 2011
The Study Application has been updated with this amendment to reflect the following changes 1 the inclusion of males who may be enrolled only in the Family Group Interview component of the study 2 the inclusion older individuals as some women may wish to include male or older members of their family in Family Group Interview portion of the study To reflect this change the maximum age for study participants has been increased to 100 years of age and males are no longer listed as excluded from the study
Objectives
For follow-up to previous study
-- Conduct follow-up telephone interviews with participants who were newly-tested at the time of original data collection to increase understanding of their mutation-positive experience longitudinally
For 25 Under study
Conduct two 2 focus group sessions at the Joining FORCES Annual Conference focusing on the unique genetic counseling and support needs of women who consider or undergo genetic testing for BRCA12 prior to age 25
Eligibility
For follow-up to previous study
-- Individuals who were in the process of making decisions relative to their status as mutation positive at the time of their previous interviews will be re-interviewed in order to learn about their longitudinal experiences and expand the data set
For 25 Under study
Women aged 18-24 who have received a positive BRCA12 mutation test result
Women aged 25-30 who considered or completed genetic testing for BRCA12 prior to their 25th birthdays
English-speaking
Attending the 2011 Joining FORCES Annual Conference
Design
For follow-up to previous study
Individuals will be invited to participate in a second telephone interview during which they will be asked to describe their mutation-related experience since their previous interviews approximately two years ago
Questions for each participant will be specifically tailored based on their previous interview data Telephone interviews are anticipated to be approximately 60 minutes in length
Note In cases where an individual eligible for follow-up is also participating in the multi-generational family interview see Amendment A the individual interview conducted as part of that study will take the place of a follow-up telephone interview
For 25 Under Study
Individuals who meet eligibility criteria will be invited to participate in either of two focus group sessions being held during the FORCE conference
Following the conference each participant will be contacted via telephone to complete a brief family history interview in order to provide context for the data collected during the focus group
Focus groups will be conducted using a prepared guide see attachment
Participants will be entered into a raffle at each session and one participant in each session will win a 50 gift card
Focus group sessions and telephone family history interviews will be audio recorded then they will be transcribed and analyzed using modified grounded theoretical design and QSR NVivo v8 software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 09-C-N074 | None | None | None |