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

NCT03225170 | Completed Results

• 2 other identifiers: 99991713217-HG-N132
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Decision-Making; BRCA1; BRCA2; Genetic Counseling; HBOC

Outcome Measures

Primary Outcomes (7)

• Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing

  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

  Assessed within 1 week after completing the genetic counseling session

• Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result

  Intention to talk with family was measured with a single categorical survey item, "Which best describes your plans to talk with your family members about genetic testing results (check the one answer that is most true for you)?"

  Assessed within 1 week after completing the genetic counseling session

• Likelihood of Talking With Family Members

  Likelihood of talking with family members was measured with a single survey item on a 7 point scale, "How likely are you to share results with the relatives you selected?" with 1= Extremely unlikely; 7=Extremely likely

  Assessed within 1 week after completing the genetic counseling session

• Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing

  Decision Self-efficacy was measured with the 12 item Decision Self-efficacy Scale by O'Connor, 1995. Scores ranged from 1-5 with higher average scores indicating higher decision self-efficacy

  Assessed within 1 week after completing the genetic counseling session

• Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session

  Hereditary Breast and Ovarian Cancer (HBOC) Knowledge was measured with an adapted 7-question scale based on the National Center for Human Genome Research Knowledge (NCHGRK) Scale \[Scherr et al. 2015; Kaphingst et al. 2012\]. All questions in the scale were presented as True/False. Each question in the scale had a correct answer (coded as 1) and incorrect answer (coded as 0). This adapted HBOC Knowledge Scale score was calculated by summing the total value across the seven questions, with a range of 0 (minimum score, all incorrect) to 7 (maximum score, all correct). Higher score indicates higher knowledge.

  Assessed within one week after completing the genetic counseling session

• 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)

  Patient empowerment (client completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment.

  Assessed within one week after completing the genetic counseling session

• 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)

  Patient empowerment (genetic counselor completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment

  Assessed immediately after completing the genetic counseling visit

Secondary Outcomes (11)

• Mammogram Intention After Counseling: Likelihood of Getting a Mammogram

  Assessed within one week after completing the genetic counseling session

• Client Anxiety After Writing Exercise and Prior to Counseling

  Assessed immediately after completing the writing exercise and prior to the genetic counseling session

• Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise

  Assessed within one week after completing the genetic counseling session

• Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients

  Assessed within one week after completing the genetic counseling session

• Perception That Intervention Improved Genetic Counseling Visit: Number of Clients

  Within 1 week after completing the genetic counseling session

Study Arms (2)

Self-affirmation (SA) group

EXPERIMENTAL

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

Behavioral: Self Affirmation (SA)

Control group

SHAM COMPARATOR

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

Behavioral: Control

Interventions

Self Affirmation (SA) BEHAVIORAL

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.

Self-affirmation (SA) group

Control BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

St. Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Related Publications (4)

• 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.

  PMID: 26389838 RESULT

• 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.

  PMID: 22694298 RESULT

• 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.

  PMID: 16055644 RESULT

• 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.

  PMID: 28206787 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Lori Erby
• Organization: NHGRI

lori.erby@nih.gov

301-443-2635

Study Officials

• Lori Erby, Ph.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 21, 2017
• Study Start: August 15, 2017
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: May 29, 2024
• Results First Posted: January 11, 2022

Record last verified: 2020-06-29

Locations

US (1)