N/A
N=47
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03225170 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing — 14; 15; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self Affirmation (SA) (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Human Genome Research Institute (NHGRI)
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing |
14; 15; 2; 0; 2; 1 | — |
| PRIMARY Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result |
0; 0; 1; 1; 3; 2 | — |
| PRIMARY Likelihood of Talking With Family Members |
6.74; 6.88 | — |
| PRIMARY Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing |
4.95; 4.85 | — |
| PRIMARY Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session |
5.78; 6.12 | — |
| PRIMARY Patient Empowerment (Client Completed): Ability to Manage Information and Risk Associated With Hereditary Breast and Ovarian Cancer (HBOC) (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope) |
5.86; 5.83 | — |
| PRIMARY Patient Empowerment (Genetic Counselor Completed): Client's Ability to Manage Information and Risk Associated With HBOC (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope) |
5.69; 5.73 | — |
| SECONDARY Mammogram Intention After Counseling: Likelihood of Getting a Mammogram |
6.78; 6.94 | — |
| SECONDARY Client Anxiety After Writing Exercise and Prior to Counseling |
2.54; 2.43 | — |
| SECONDARY Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise |
0; 0; 19; 17 | — |
| SECONDARY Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients |
0; 0; 19; 17 | — |
| SECONDARY Perception That Intervention Improved Genetic Counseling Visit: Number of Clients |
6; 3; 13; 14 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention |
57.0; 26.2 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value |
13.4; 11.4 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used |
32.5; 3.8 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used |
1.6; 0.2 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Essay Attitude Strength |
5.4; 2.3 | — |
| SECONDARY Level of Engagement With the Writing Exercise: Self-affirmation Score |
3.7; 1.7 | — |
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. Luke's 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.
Eligibility Criteria
INCLUSION CRITERIA
Client Participants:
- Must be female, at least 18 years old
- Have an initial appointment for genetic counseling for HBOC risk at St. Luke's Health System
- Must be able to read and write in English to participate
- Pregnant women will be included
Genetic Counselor (GC) Participants:
-Must be certified GCs who see clients with an indication for HBOC related genetic counseling at St. Luke's Health System
EXCLUSION CRITERIA
- Non-English speakers and illiterate subjects will be excluded
- Clients who are unable to provide consent will be excluded
Data sourced from ClinicalTrials.gov (NCT03225170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.