Breast Cancer
Conditions
Keywords
Decision-Making, BRCA1, BRCA2, Genetic Counseling, HBOC
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.
Interventions
BEHAVIORALSelf Affirmation (SA)
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.
BEHAVIORALControl
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.
Sponsors
National Human Genome Research Institute (NHGRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | 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 |
| Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | 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)? |
| Likelihood of Talking With Family Members | 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 |
| Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing | 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 |
| Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session | 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 higher knowledge. |
| 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) | 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. |
| 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used | At the time of the intervention | Number of Words in Writing Intervention Discussing How Value Was Recently Used was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing how the value was recently used. |
| Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used | At the time of the intervention | Number of Examples of How Value was Recently Used was measured by counting the number of unique examples offered in the essay as coded by two coders. |
| Mammogram Intention After Counseling: Likelihood of Getting a Mammogram | 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 |
| Level of Engagement With the Writing Exercise: Self-affirmation Score | At the time of the intervention | Self-affirmation score is a measure of the extent to which the essay appeared to be self-affirming for the participant. Two independent raters scored a subset of essays using a system based on procedures described in Harris & Napper (2005) and Ferrer et al. (2017) using the following instructions: Setting aside your own opinions and values, how self-affirmed would you estimate the writer of this passage to have been (at the end)? Raters scored each essay and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated the value was important but did not include descriptions of why the value was important to the participant. A control group participant received a score of 1 if they followed the writing activity's instructions exactly. A score of 5 (maximum) indicated that the essay elaborated on why the value was important. |
| Level of Engagement With the Writing Exercise: Essay Attitude Strength | At the time of the intervention | Essay Attitude Strength is a measure of the extent to which the participant's essay demonstrated the importance of the value selected during the writing exercise. Two independent raters read a subset of the essays and used a scoring system based on the procedure described in Harris & Napper (2005). Each rater gave the participant's essay a numeric score between 1 and 7, and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated that the selected value appeared to be not at all important to the participant. A score of 7 (maximum) indicated that the selected value appeared to be very important to the participant. |
| Client Anxiety After Writing Exercise and Prior to Counseling | 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 |
| 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 | 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 |
| Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients | 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 |
| Perception That Intervention Improved Genetic Counseling Visit: Number of Clients | 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 |
| Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention | At the time of the intervention | Number of words in writing intervention was measured by counting the number of words in the essay written by the client |
| Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value | At the time of the intervention | Number of Words in Writing Intervention Discussing Importance of Selected Value was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing the importance of the selected value, as coded by two coders. |
Countries
United States
Participant flow
Pre-assignment details
Of the 64 participants consented to the study, 17 participants withdrew prior to randomization and 47 participants started the study.
Participants by arm
| Arm | Count |
|---|---|
| Self-affirmation (SA) Group 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 | 23 |
| Control Group 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 | 22 |
| Genetic Counselor (GC) 1. Genetic Counselors (GC) provided their Standard of Care treatment, blinded to clients' enrollment in SA intervention or Control group and assessed each client's empowerment at the end of each session.
2. GC also completed a survey at the end of the study to assess the writing exercise and the feasibility of SA for larger studies. | 2 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not complete intervention/control writing exercise | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 4 | 0 |
Baseline characteristics
| Characteristic | Self-affirmation (SA) Group | Control Group | Genetic Counselor (GC) | Total |
|---|---|---|---|---|
| Age, Customized >=18 to <65 years | 15 Participants | 8 Participants | 0 Participants | 23 Participants |
| Age, Customized >=65 years | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Age, Customized Age Unknown (years) | 6 Participants | 11 Participants | 2 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 0 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 2 Participants | 11 Participants |
| Race (NIH/OMB) White | 16 Participants | 17 Participants | 0 Participants | 33 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 2 participants | 47 participants |
| Sex/Gender, Customized Female | 23 Participants | 22 Participants | 0 Participants | 45 Participants |
| Sex/Gender, Customized Gender unknown | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
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.
Time frame: Assessed within one week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session | 5.78 units on a scale | Standard Deviation 0.88 |
| Control Group | Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session | 6.12 units on a scale | Standard Deviation 1.05 |
Primary
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
Time frame: Assessed within 1 week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing | 4.95 units on a scale | Standard Deviation 0.09 |
| Control Group | Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing | 4.85 units on a scale | Standard Deviation 0.26 |
Primary
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
Time frame: Assessed within 1 week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Likelihood of Talking With Family Members | 6.74 units on a scale | Standard Deviation 0.56 |
| Control Group | Likelihood of Talking With Family Members | 6.88 units on a scale | Standard Deviation 0.33 |
Primary
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)?
Time frame: Assessed within 1 week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to only a few people who are closest to me | 1 Participants |
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to most of my first and second degree relatives who are at risk for cancer | 3 Participants |
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I don't plan to talk to anyone | 0 Participants |
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to almost all of my first and second degree relatives who are at risk for cancer | 2 Participants |
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to some of my family members | 3 Participants |
| Self-affirmation (SA) Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to almost all of my family members | 10 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to some of my family members | 2 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I don't plan to talk to anyone | 0 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to only a few people who are closest to me | 1 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to almost all of my family members | 8 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to most of my first and second degree relatives who are at risk for cancer | 6 Participants |
| Control Group | Number of Clients Who Indicated Intention to Talk With Family About Genetic Testing Result | I plan to talk to almost all of my first and second degree relatives who are at risk for cancer | 0 Participants |
Primary
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.
Time frame: Assessed within one week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | 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) | 5.86 units on a scale | Standard Deviation 0.65 |
| Control Group | 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) | 5.83 units on a scale | Standard Deviation 0.67 |
Primary
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
Time frame: Assessed immediately after completing the genetic counseling visit
Population: The genetic counselor analysis included all clients who had a genetic counseling session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | 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) | 5.69 units on a scale | Standard Deviation 0.51 |
| Control Group | 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) | 5.73 units on a scale | Standard Deviation 0.59 |
Primary
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
Time frame: Assessed within 1 week after completing the genetic counseling session
Population: The analysis included clients who were offered genetic testing in the session and completed the post-genetic counseling session survey. Two clients, one in each arm, were not offered genetic testing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-affirmation (SA) Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = Yes | 14 Participants |
| Self-affirmation (SA) Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = No | 2 Participants |
| Self-affirmation (SA) Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = Maybe | 2 Participants |
| Control Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = Yes | 15 Participants |
| Control Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = No | 0 Participants |
| Control Group | Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing | Response = Maybe | 1 Participants |
Secondary
Client Anxiety After Writing Exercise and Prior to Counseling
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
Time frame: Assessed immediately after completing the writing exercise and prior to the genetic counseling session
Population: The analysis included clients who completed the writing activity. One client in the control group skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Client Anxiety After Writing Exercise and Prior to Counseling | 2.54 units on a scale | Standard Deviation 0.77 |
| Control Group | Client Anxiety After Writing Exercise and Prior to Counseling | 2.43 units on a scale | Standard Deviation 0.81 |
Secondary
Level of Engagement With the Writing Exercise: Essay Attitude Strength
Essay Attitude Strength is a measure of the extent to which the participant's essay demonstrated the importance of the value selected during the writing exercise. Two independent raters read a subset of the essays and used a scoring system based on the procedure described in Harris & Napper (2005). Each rater gave the participant's essay a numeric score between 1 and 7, and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated that the selected value appeared to be not at all important to the participant. A score of 7 (maximum) indicated that the selected value appeared to be very important to the participant.
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Essay Attitude Strength | 5.4 units on a scale | Standard Deviation 2.5 |
| Control Group | Level of Engagement With the Writing Exercise: Essay Attitude Strength | 2.3 units on a scale | Standard Deviation 1.3 |
Secondary
Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used
Number of Examples of How Value was Recently Used was measured by counting the number of unique examples offered in the essay as coded by two coders.
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used | 1.6 unique examples | Standard Deviation 1.4 |
| Control Group | Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used | 0.2 unique examples | Standard Deviation 0.4 |
Secondary
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention
Number of words in writing intervention was measured by counting the number of words in the essay written by the client
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention | 57.0 words | Standard Deviation 45.7 |
| Control Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention | 26.2 words | Standard Deviation 15.3 |
Secondary
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used
Number of Words in Writing Intervention Discussing How Value Was Recently Used was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing how the value was recently used.
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used | 32.5 words | Standard Deviation 33.8 |
| Control Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used | 3.8 words | Standard Deviation 6.6 |
Secondary
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value
Number of Words in Writing Intervention Discussing Importance of Selected Value was measured by counting the number of words in the essay written by the client that were in phrases that were focused on discussing the importance of the selected value, as coded by two coders.
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value | 13.4 words | Standard Deviation 12.1 |
| Control Group | Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value | 11.4 words | Standard Deviation 10 |
Secondary
Level of Engagement With the Writing Exercise: Self-affirmation Score
Self-affirmation score is a measure of the extent to which the essay appeared to be self-affirming for the participant. Two independent raters scored a subset of essays using a system based on procedures described in Harris & Napper (2005) and Ferrer et al. (2017) using the following instructions: Setting aside your own opinions and values, how self-affirmed would you estimate the writer of this passage to have been (at the end)? Raters scored each essay and the two scores were examined for inter-rater reliability. The primary rater then rated the remaining essays and the final score was the rating assigned by the primary rater for all essays. A score of 1 (minimum) indicated the value was important but did not include descriptions of why the value was important to the participant. A control group participant received a score of 1 if they followed the writing activity's instructions exactly. A score of 5 (maximum) indicated that the essay elaborated on why the value was important.
Time frame: At the time of the intervention
Population: The analysis included clients who completed the writing intervention. Two clients skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Level of Engagement With the Writing Exercise: Self-affirmation Score | 3.7 units on a scale | Standard Deviation 1.2 |
| Control Group | Level of Engagement With the Writing Exercise: Self-affirmation Score | 1.7 units on a scale | Standard Deviation 1 |
Secondary
Mammogram Intention After Counseling: Likelihood of Getting a Mammogram
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
Time frame: Assessed within one week after completing the genetic counseling session
Population: The analysis included clients who completed this item on the post-genetic counseling session survey. Two clients, one from each group, skipped the item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-affirmation (SA) Group | Mammogram Intention After Counseling: Likelihood of Getting a Mammogram | 6.78 units on a scale | Standard Deviation 1.71 |
| Control Group | Mammogram Intention After Counseling: Likelihood of Getting a Mammogram | 6.94 units on a scale | Standard Deviation 0.25 |
Secondary
Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
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
Time frame: Assessed within one week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-affirmation (SA) Group | Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise | Response = Yes | 0 Participants |
| Self-affirmation (SA) Group | Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise | Response = No | 19 Participants |
| Control Group | Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise | Response = Yes | 0 Participants |
| Control Group | Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise | Response = No | 17 Participants |
Secondary
Perception That Intervention Improved Genetic Counseling Visit: Number of Clients
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
Time frame: Within 1 week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-affirmation (SA) Group | Perception That Intervention Improved Genetic Counseling Visit: Number of Clients | Response = Yes | 6 Participants |
| Self-affirmation (SA) Group | Perception That Intervention Improved Genetic Counseling Visit: Number of Clients | Response = No | 13 Participants |
| Control Group | Perception That Intervention Improved Genetic Counseling Visit: Number of Clients | Response = Yes | 3 Participants |
| Control Group | Perception That Intervention Improved Genetic Counseling Visit: Number of Clients | Response = No | 14 Participants |
Secondary
Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients
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
Time frame: Assessed within one week after completing the genetic counseling session
Population: The analysis included clients who completed the post-genetic counseling session survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self-affirmation (SA) Group | Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients | Response = Yes | 0 Participants |
| Self-affirmation (SA) Group | Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients | Response = No | 19 Participants |
| Control Group | Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients | Response = Yes | 0 Participants |
| Control Group | Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients | Response = No | 17 Participants |