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NCT03225170 · ClinicalTrials.gov registry record · NA
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
A NA study, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT03225170: Completed NA study, sponsored by National Human Genome Research Institute (NHGRI).
NCT03225170 is a NA study that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03225170, a NA study, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
Intention to have genetic testing was measured with a single survey item, "Do you plan to have genetic testing?" with response options of yes=1; maybe=2; no=3
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Self Affirmation (SA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2020-06-29 |
| Phase | NA |
What the finished NCT03225170 record still lists
NCT03225170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT03225170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03225170 about?
NCT03225170 is a clinical study titled "Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling". 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. Research...
What is the current status of trial NCT03225170?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2017-08-15. Estimated completion is 2020-06-29.
What interventions are being tested in trial NCT03225170?
The interventions under investigation include: Control (BEHAVIORAL), Self Affirmation (SA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03225170?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03225170's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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