NCT03225170

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

Completed NA Results posted Last updated 29 May 2024

What this trial tests

NA trial testing Self Affirmation (SA) in Breast Cancer in 64 participants. Completed in 29 June 2020.

Timeline

15 August 2017

Primary endpoint
29 June 2020

29 June 2020

Quick facts

Lead sponsor	National Human Genome Research Institute (NHGRI)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	64
Start date	15 August 2017
Primary completion	29 June 2020
Estimated completion	29 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Self Affirmation (SA)
• Control

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Human Genome Research Institute (NHGRI)

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing Primary · Assessed within 1 week after completing the genetic counseling session

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

Response = Yes

Group	Value	95% CI
Self-affirmation (SA) Group	14
Control Group	15

Response = No

Group	Value	95% CI
Self-affirmation (SA) Group	2
Control Group	0

Response = Maybe

Group	Value	95% CI
Self-affirmation (SA) Group	2
Control Group	1

Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result Primary · Assessed within 1 week after completing the genetic counseling session

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)?"

"I don't plan to talk to anyone"

Group	Value	95% CI
Self-affirmation (SA) Group	0
Control Group	0

"I plan to talk to only a few people who are closest to me"

Group	Value	95% CI
Self-affirmation (SA) Group	1
Control Group	1

"I plan to talk to some of my family members"

Group	Value	95% CI
Self-affirmation (SA) Group	3
Control Group	2

"I plan to talk to most of my first and second degree relatives who are at risk for cancer"

Group	Value	95% CI
Self-affirmation (SA) Group	3
Control Group	6

"I plan to talk to almost all of my first and second degree relatives who are at risk for cancer"

Group	Value	95% CI
Self-affirmation (SA) Group	2
Control Group	0

"I plan to talk to almost all of my family members"

Group	Value	95% CI
Self-affirmation (SA) Group	10
Control Group	8

Likelihood of Talking With Family Members Primary · Assessed within 1 week after completing the genetic counseling session

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

Group	Value	95% CI
Self-affirmation (SA) Group	6.74	± 0.56
Control Group	6.88	± 0.33

Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing Primary · Assessed within 1 week after completing the genetic counseling session

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

Group	Value	95% CI
Self-affirmation (SA) Group	4.95	± 0.09
Control Group	4.85	± 0.26

Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session Primary · Assessed within one week after completing the genetic counseling 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 hig

Group	Value	95% CI
Self-affirmation (SA) Group	5.78	± 0.88
Control Group	6.12	± 1.05

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) Primary · Assessed within one week after completing the genetic counseling session

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.

Group	Value	95% CI
Self-affirmation (SA) Group	5.86	± 0.65
Control Group	5.83	± 0.67

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) Primary · Assessed immediately after completing the genetic counseling visit

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

Group	Value	95% CI
Self-affirmation (SA) Group	5.69	± 0.51
Control Group	5.73	± 0.59

Mammogram Intention After Counseling: Likelihood of Getting a Mammogram Secondary · Assessed within one week after completing the genetic counseling session

Mammogram intention was measured with a single survey item on a 7 point scale "How likely are you to get regular mammograms?" with 1= Extremely unlikely to 7=Extremely likely

Group	Value	95% CI
Self-affirmation (SA) Group	6.78	± 1.71
Control Group	6.94	± 0.25

Client Anxiety After Writing Exercise and Prior to Counseling Secondary · Assessed immediately after completing the writing exercise and prior to the genetic counseling session

Patient anxiety was measured using the 6 item short version of the Spielberger State Anxiety Scale, a 4-point scale; 1= not at all, 2=somewhat, 3=moderately, 4= very much. Higher score indicates higher anxiety

Group	Value	95% CI
Self-affirmation (SA) Group	2.54	± 0.77
Control Group	2.43	± 0.81

Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise Secondary · Assessed within one week after completing the genetic counseling session

Perceived effect of writing exercise on genetic counseling visit was measured using a single item "The values writing activity affected my appointment"; 1=yes; 2=no

Response = Yes

Group	Value	95% CI
Self-affirmation (SA) Group	0
Control Group	0

Response = No

Group	Value	95% CI
Self-affirmation (SA) Group	19
Control Group	17

Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients Secondary · Assessed within one week after completing the genetic counseling session

Perception that writing exercise hindered the genetic counseling visit was measured using a single survey item "The values writing activity hindered my interaction with my genetic counselor"; 1=yes; 2=no

Response = Yes

Group	Value	95% CI
Self-affirmation (SA) Group	0
Control Group	0

Response = No

Group	Value	95% CI
Self-affirmation (SA) Group	19
Control Group	17

Perception That Intervention Improved Genetic Counseling Visit: Number of Clients Secondary · Within 1 week after completing the genetic counseling session

Perception that intervention improved the genetic counseling visit was measured using a single survey item "The values writing activity improved my interaction with my genetic counselor"; 1=yes; 2=no

Response = Yes

Group	Value	95% CI
Self-affirmation (SA) Group	6
Control Group	3

Response = No

Group	Value	95% CI
Self-affirmation (SA) Group	13
Control Group	14

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.