Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03225170
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2017-07-20
Brief Title:
Is it Feasible Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Is it Feasible Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Status:
COMPLETED
Status Verified Date:
2020-06-29
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
Some women have a high chance of developing breast and ovarian cancer because of a change in a gene that is passed within a family from one generation to the next These women with hereditary breast and ovarian cancer HBOC have to make hard choices about tests and treatments Researchers want to study how to help women to feel ready to make those choices A kind of writing exercise might help if it is done before genetic counseling This writing exercise is called a self-affirmation SA exercise It may lead to better communication during counseling and better behavioral outcomes
Objective
To see if an SA exercise done before HBOC genetic counseling could improve client communication and behavior
Eligibility
Clients Adult female 18 years of age with initial appointment for HBOC risk with genetic counselor at St Lukes Health System
Genetic Counselors Genetic counselors 18 years of age providing genetic counseling to clients at risk for HBOC
Design
Clients will be screened by phone prior to their genetic counseling appointment
They will arrive 15 minutes early to their appointment
They will do a 10 to 15 minute survey and writing exercise This includes questions about
Things that are important to them
How they are feeling prior to the appointment
After their genetic counseling appointment they will take a 10- to 15-minute follow-up survey It can be in the office or online It will include questions about
How they felt about the writing exercise
How they felt about their genetic counseling
If they had cancer
If they were offered and had genetic testing
Genetic counselor participants will take a 2 to 5 minute survey after each session with a client in the study This will include questions about how the client was in the session They also will take a 10 to 15 minute survey at the end of the study It will be about their opinions on the process of having their clients complete the writing exercise
Some women have a high chance of developing breast and ovarian cancer because of a change in a gene that is passed within a family from one generation to the next These women with hereditary breast and ovarian cancer HBOC have to make hard choices about tests and treatments Researchers want to study how to help women to feel ready to make those choices A kind of writing exercise might help if it is done before genetic counseling This writing exercise is called a self-affirmation SA exercise It may lead to better communication during counseling and better behavioral outcomes
Objective
To see if an SA exercise done before HBOC genetic counseling could improve client communication and behavior
Eligibility
Clients Adult female 18 years of age with initial appointment for HBOC risk with genetic counselor at St Lukes Health System
Genetic Counselors Genetic counselors 18 years of age providing genetic counseling to clients at risk for HBOC
Design
Clients will be screened by phone prior to their genetic counseling appointment
They will arrive 15 minutes early to their appointment
They will do a 10 to 15 minute survey and writing exercise This includes questions about
Things that are important to them
How they are feeling prior to the appointment
After their genetic counseling appointment they will take a 10- to 15-minute follow-up survey It can be in the office or online It will include questions about
How they felt about the writing exercise
How they felt about their genetic counseling
If they had cancer
If they were offered and had genetic testing
Genetic counselor participants will take a 2 to 5 minute survey after each session with a client in the study This will include questions about how the client was in the session They also will take a 10 to 15 minute survey at the end of the study It will be about their opinions on the process of having their clients complete the writing exercise
Detailed Description:
The proposed study is a feasibility study to assess the viability of implementing a Self-Affirmation SA intervention in a Hereditary Breast and Ovarian Cancer HBOC genetic counseling clinic to improve client communication and behavioral outcomes Participants will be clients and genetic counselors at the St Lukes Hospital System HBOC clinic This study seeks to identify outcomes that would be most informative in a large-scale research protocol As outcomes we will assess clients decision self-efficacy intention to talk with family genetic test uptake empowerment and HBOC knowledge We will also assess genetic counselors and clients perceived benefits perceived harms and acceptance of the affirmation intervention
In this study clients will be invited to participate in an intervention before their genetic counseling appointment The SA intervention is a short written exercise to reinforce clients self-integrity a global sense of personal adequacy leading to more openness to threatening information within the genetic counseling session Clients and genetic counselors will be surveyed to assess outcome measures and feasibility of the intervention
Social science research has shown that when people are faced with threatening information they often seek to protect themselves and reject the threatening message Message rejection can include minimizing the importance or discrediting the truth of the message SA interventions aim to bolster self-integrity or esteem by focusing on aspects of participants lives they value and thereby improving participants self-perception and tolerance towards threatening messages SA manipulations have been shown to increase patient communication within appointments and both intentions and actions toward behavior change
Often in cancer genetic counseling appointments clients are confronted with the threat of having a significantly increased risk for cancers while being asked to make a decision about genetic testing A self-affirmation intervention may facilitate greater client decision self-efficacy empowerment and positive behavior outcomes such as communication with family regarding genetic risk and screening behaviors
In this study clients will be invited to participate in an intervention before their genetic counseling appointment The SA intervention is a short written exercise to reinforce clients self-integrity a global sense of personal adequacy leading to more openness to threatening information within the genetic counseling session Clients and genetic counselors will be surveyed to assess outcome measures and feasibility of the intervention
Social science research has shown that when people are faced with threatening information they often seek to protect themselves and reject the threatening message Message rejection can include minimizing the importance or discrediting the truth of the message SA interventions aim to bolster self-integrity or esteem by focusing on aspects of participants lives they value and thereby improving participants self-perception and tolerance towards threatening messages SA manipulations have been shown to increase patient communication within appointments and both intentions and actions toward behavior change
Often in cancer genetic counseling appointments clients are confronted with the threat of having a significantly increased risk for cancers while being asked to make a decision about genetic testing A self-affirmation intervention may facilitate greater client decision self-efficacy empowerment and positive behavior outcomes such as communication with family regarding genetic risk and screening behaviors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 17-HG-N132 | None | None | None |