Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling

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.

Conditions

• Breast Cancer

Interventions

BEHAVIORAL

Self Affirmation (SA)

Clients will be asked to rank artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity from most important to least important. They will then be asked to write about the item that is most important to them and why it may be important to them.

BEHAVIORAL

Control

Clients will be asked to rank artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity from most important to least important. The control group will rank the list and be asked to write about the 9th ranked item and why it might be important to someone else.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI)

  lead NIH

Principal Investigators

• Lori Erby, Ph.D. · National Human Genome Research Institute (NHGRI)

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-15

Primary Completion

2020-06-29

Completion

2020-06-29

Countries

• United States

Study Locations