Purpose

Background: Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about tests and treatment. Researchers want to study the best way to guide them. A kind of writing exercise might help if it is done before genetic counseling. It is called a self-affirmation (SA) exercise. It may lead to better communication in the counseling and better behavioral outcomes. Objective: To test if an SA exercise done with HBOC genetic counseling could improve client communication and behavior. Eligibility: Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients Design: Appointment participants will be screened by phone. 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: If they have cancer If they have had or were offered genetic counseling Things that are important to them After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the office or online. It includes questions about how they felt about the writing exercise and their counseling. Counselor participants will take a 2- to 5-minute survey after sessions with clients in the study. This includes questions about how the client was in the session. They will take a 10- to 15-minute survey at the end of the study. It will be about their opinions of the writing exercise.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.
  • Participants must be able to read and write in English to participate.
  • Pregnant women will be included.

Exclusion Criteria

  • Non-English speakers and illiterate subjects will be excluded.
  • Clients who are unable to provide consent will be excluded.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
Single (Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Control
The control group will 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 9th ranked item and why it might be important to someone else. The control condition is consistent with the control used in other SA intervention studies. The 9th ranked item is chosen to inhibit a reverse effect, where participants feel affirmed because they do not value something that is averse to them.
  • Behavioral: Self Affirmation
    Participants 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. The control group will rank the same list and be asked to will write about the 9th ranked item and why it might be important to someone else. The treatment and control condition are consistent with interventions used in other SA intervention studies.
Experimental
Intervention
Arm Description: Participants 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: Self Affirmation
    Participants 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. The control group will rank the same list and be asked to will write about the 9th ranked item and why it might be important to someone else. The treatment and control condition are consistent with interventions used in other SA intervention studies.

More Details

Status
Completed
Sponsor
National Human Genome Research Institute (NHGRI)

Study Contact

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. Luke s 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 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 counselors will be surveyed after the study 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 by focusing on aspects of subject s 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 of 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.