Trial Outcomes & Findings for Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling (NCT NCT03225170)
NCT ID: NCT03225170
Last Updated: 2024-05-29
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Assessed within 1 week after completing the genetic counseling session
Results posted on
2024-05-29
Participant Flow
Of the 64 participants consented to the study, 17 participants withdrew prior to randomization and 47 participants started the study.
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
2
|
|
Overall Study
COMPLETED
|
19
|
17
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
0
|
|
Overall Study
Did not complete intervention/control writing exercise
|
0
|
1
|
0
|
Baseline Characteristics
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
Baseline characteristics by cohort
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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
|
Control Group
n=22 Participants
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
|
Genetic Counselor (GC)
n=2 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
>=18 to <65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
Age Unknown (years)
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
2 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed within 1 week after completing the genetic counseling sessionPopulation: 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.
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=18 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=16 Participants
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
|
|---|---|---|
|
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
Response = Yes
|
14 Participants
|
15 Participants
|
|
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
Response = No
|
2 Participants
|
0 Participants
|
|
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
Response = Maybe
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Assessed within 1 week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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)?"
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result
"I don't plan to talk to anyone"
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
2 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
8 Participants
|
PRIMARY outcome
Timeframe: Assessed within 1 week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Likelihood of Talking With Family Members
|
6.74 units on a scale
Standard Deviation 0.56
|
6.88 units on a scale
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Assessed within 1 week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing
|
4.95 units on a scale
Standard Deviation 0.09
|
4.85 units on a scale
Standard Deviation 0.26
|
PRIMARY outcome
Timeframe: Assessed within one week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session
|
5.78 units on a scale
Standard Deviation 0.88
|
6.12 units on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: Assessed within one week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
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
|
5.83 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: Assessed immediately after completing the genetic counseling visitPopulation: The genetic counselor analysis included all clients who had a genetic counseling session
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=22 Participants
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
|
|---|---|---|
|
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
|
5.73 units on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Assessed within one week after completing the genetic counseling sessionPopulation: The analysis included clients who completed this item on the post-genetic counseling session survey. Two clients, one from each group, skipped the item.
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=18 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=16 Participants
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
|
|---|---|---|
|
Mammogram Intention After Counseling: Likelihood of Getting a Mammogram
|
6.78 units on a scale
Standard Deviation 1.71
|
6.94 units on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Assessed immediately after completing the writing exercise and prior to the genetic counseling sessionPopulation: The analysis included clients who completed the writing activity. One client in the control group skipped the item.
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=21 Participants
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
|
|---|---|---|
|
Client Anxiety After Writing Exercise and Prior to Counseling
|
2.54 units on a scale
Standard Deviation 0.77
|
2.43 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Assessed within one week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
Response = Yes
|
0 Participants
|
0 Participants
|
|
Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
Response = No
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Assessed within one week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients
Response = Yes
|
0 Participants
|
0 Participants
|
|
Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients
Response = No
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Within 1 week after completing the genetic counseling sessionPopulation: The analysis included clients who completed the post-genetic counseling session survey
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
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=19 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=17 Participants
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
|
|---|---|---|
|
Perception That Intervention Improved Genetic Counseling Visit: Number of Clients
Response = Yes
|
6 Participants
|
3 Participants
|
|
Perception That Intervention Improved Genetic Counseling Visit: Number of Clients
Response = No
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
Number of words in writing intervention was measured by counting the number of words in the essay written by the client
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention
|
57.0 words
Standard Deviation 45.7
|
26.2 words
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
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
|
11.4 words
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
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
|
3.8 words
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used
|
1.6 unique examples
Standard Deviation 1.4
|
0.2 unique examples
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
Level of Engagement With the Writing Exercise: Essay Attitude Strength
|
5.4 units on a scale
Standard Deviation 2.5
|
2.3 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: At the time of the interventionPopulation: The analysis included clients who completed the writing intervention. Two clients skipped the item.
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.
Outcome measures
| Measure |
Self-affirmation (SA) Group
n=23 Participants
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 counseling session, clients were required to fill out a post session questionnaire
|
Control Group
n=20 Participants
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
|
|---|---|---|
|
Level of Engagement With the Writing Exercise: Self-affirmation Score
|
3.7 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.0
|
Adverse Events
Self-affirmation (SA) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place