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

National Institutes of Health (NIH)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Self Affirmation (SA); Behavioral: Control

Study type: Interventional

Funder types: NIH

Identifiers

NCT03225170

17-HG-N132

999917132

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Self-affirmation (SA) group

Experimental group

Description:

Immediately prior to the scheduled cancer genetic counseling appointment, clients: 1. completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (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 and to elaborate on one that was most important to them and why; 2. 6-item standardized measure of anxiety questionnaire; 3. after the genetic counseling session, clients were required to fill out a post session questionnaire

Treatment:

Behavioral: Self Affirmation (SA)

Control group

Sham Comparator group

Description:

Immediately prior to the scheduled cancer genetic counseling appointment, clients: 1. completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (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 and to elaborate on the 9th ranked item and why it might be important to someone else; 2. 6-item standardized measure of anxiety questionnaire; 3. after the genetic counseling session, clients were required to fill out a post session questionnaire

Treatment:

Behavioral: Control