Clinical trial · Interventional
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| Self Affirmation (SA) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-affirmation (SA) 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
- interventionNames
- Behavioral: Self Affirmation (SA)
- type
- SHAM_COMPARATOR
- label
- Control 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTScherr 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
- RESULTKaphingst 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
- RESULTHarris 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
- RESULTFerrer 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