Clinical trial NCT03225170: Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Official title: Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Decision-Making
BRCA1
BRCA2
Genetic Counseling
HBOC
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-07-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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.

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

Primary outcomes:
measure: Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
timeFrame: Assessed within 1 week after completing the genetic counseling session
measure: Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result
timeFrame: Assessed within 1 week after completing the genetic counseling session
measure: Likelihood of Talking With Family Members
timeFrame: Assessed within 1 week after completing the genetic counseling session
measure: Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing
timeFrame: Assessed within 1 week after completing the genetic counseling session
measure: Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session
timeFrame: Assessed within one week after completing the genetic counseling session
measure: 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)
timeFrame: Assessed within one week after completing the genetic counseling session
measure: 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)
timeFrame: Assessed immediately after completing the genetic counseling visit
Secondary outcomes:
measure: Mammogram Intention After Counseling: Likelihood of Getting a Mammogram
timeFrame: Assessed within one week after completing the genetic counseling session
measure: Client Anxiety After Writing Exercise and Prior to Counseling
timeFrame: Assessed immediately after completing the writing exercise and prior to the genetic counseling session
measure: Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
timeFrame: Assessed within one week after completing the genetic counseling session
measure: Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients
timeFrame: Assessed within one week after completing the genetic counseling session
measure: Perception That Intervention Improved Genetic Counseling Visit: Number of Clients
timeFrame: Within 1 week after completing the genetic counseling session
measure: Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention
timeFrame: At the time of the intervention
measure: Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value
timeFrame: At the time of the intervention
measure: Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used
timeFrame: At the time of the intervention
measure: Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used
timeFrame: At the time of the intervention
measure: Level of Engagement With the Writing Exercise: Essay Attitude Strength
timeFrame: At the time of the intervention
measure: Level of Engagement With the Writing Exercise: Self-affirmation Score
timeFrame: At the time of the intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: St. Luke's Health System
state: Missouri
Study officials:
affiliation: National Human Genome Research Institute (NHGRI)
name: Lori Erby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scherr CL, Christie J, Vadaparampil ST. Breast Cancer Survivors' Knowledge of Hereditary Breast and Ovarian Cancer following Genetic Counseling: An Exploration of General and Survivor-Specific Knowledge Items. Public Health Genomics. 2016;19(1):1-10. doi: 10.1159/000439162. Epub 2015 Sep 22.
citation: Kaphingst KA, Facio FM, Cheng MR, Brooks S, Eidem H, Linn A, Biesecker BB, Biesecker LG. Effects of informed consent for individual genome sequencing on relevant knowledge. Clin Genet. 2012 Nov;82(5):408-15. doi: 10.1111/j.1399-0004.2012.01909.x. Epub 2012 Aug 7.
citation: Harris PR, Napper L. Self-affirmation and the biased processing of threatening health-risk information. Pers Soc Psychol Bull. 2005 Sep;31(9):1250-63. doi: 10.1177/0146167205274694.
citation: Ferrer RA, Klein WM, Graff KA. Self-affirmation increases defensiveness toward health risk information among those experiencing negative emotions: Results from two national samples. Health Psychol. 2017 Apr;36(4):380-391. doi: 10.1037/hea0000460. Epub 2017 Feb 16.