Breast CancerNCT03225170
Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
A study testing Self Affirmation (SA) in people with Breast Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Self Affirmation (SA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 29 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speakers and illiterate subjects will be excluded
- Clients who are unable to provide consent will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Health System
Kansas City, Missouri, 64111
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Self Affirmation (SA), Control
- Keywords
- Decision-Making, BRCA1, BRCA2, Genetic Counseling, HBOC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Affirmation (SA)Behavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-affirmation (SA) group | Experimental | Immediately prior to the scheduled cancer genetic counseling appointment, clients:
1. completed standardized questionnaires on self-affirmation (SA) intervention that focused on positive values of personal importance. The SA intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on one that was most important to them and why;
2. 6-item standardized measure of anxiety questionnaire;
3. after the genetic counseling session, clients were required to fill out a post session questionnaire Receives: Behavioral: Self Affirmation (SA) |
| Control group | Sham comparator | Immediately prior to the scheduled cancer genetic counseling appointment, clients:
1. completed similar standardized questionnaire as the SA group, with a non-affirming exercise. The non-intervention required clients to rank 11 items (artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity) from most important to least important and to elaborate on the 9th ranked item and why it might be important to someone else;
2. 6-item standardized measure of anxiety questionnaire;
3. after the genetic counseling session, clients were required to fill out a post session questionnaire Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed within 1 week after completing the genetic counseling session
Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result
Intention to talk with family was measured with a single categorical survey item, "Which best describes your plans to talk with your family members about genetic testing results (check the one answer that is most true for you)?"
Measured: Assessed within 1 week after completing the genetic counseling session
Likelihood of Talking With Family Members
Likelihood of talking with family members was measured with a single survey item on a 7 point scale, "How likely are you to share results with the relatives you selected?" with 1= Extremely unlikely; 7=Extremely likely
Measured: Assessed within 1 week after completing the genetic counseling session
Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing
Decision Self-efficacy was measured with the 12 item Decision Self-efficacy Scale by O'Connor, 1995. Scores ranged from 1-5 with higher average scores indicating higher decision self-efficacy
Measured: Assessed within 1 week after completing the genetic counseling session
Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session
Hereditary Breast and Ovarian Cancer (HBOC) Knowledge was measured with an adapted 7-question scale based on the National Center for Human Genome Research Knowledge (NCHGRK) Scale [Scherr et al. 2015; Kaphingst et al. 2012]. All questions in the scale were presented as True/False. Each question in the scale had a correct answer (coded as 1) and incorrect answer (coded as 0). This adapted HBOC Knowledge Scale score was calculated by summing the total value across the seven questions, with a range of 0 (minimum score, all incorrect) to 7 (maximum score, all correct). Higher score indicates higher knowledge.
Measured: Assessed within one week after completing the genetic counseling session
Patient Empowerment (Client Completed): Ability to Manage Information and Risk Associated With Hereditary Breast and Ovarian Cancer (HBOC) (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope)
Patient empowerment (client completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment.
Measured: Assessed within one week after completing the genetic counseling session
Patient Empowerment (Genetic Counselor Completed): Client's Ability to Manage Information and Risk Associated With HBOC (Decisional Control, Cognitive Control, Behavioral Control, Emotional Regulation, and Hope)
Patient empowerment (genetic counselor completed) was measured with the 24 item Genetic Counseling Outcomes Scale (GCOS-24; McAllister et al, 2011) using 7-point score ranging from 1=strongly disagree to 7= strongly agree. Higher scores indicate higher empowerment
Measured: Assessed immediately after completing the genetic counseling visit
Secondary outcomes (11)
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
Measured: Assessed within one week after completing the genetic counseling session
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
Measured: Assessed immediately after completing the writing exercise and prior to the genetic counseling session
Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
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
Measured: Assessed within one week after completing the genetic counseling session
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
Measured: Assessed within one week after completing the genetic counseling session
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
Measured: Within 1 week after completing the genetic counseling session
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
Measured: At the time of the intervention
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.
Measured: At the time of the intervention
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.
Measured: At the time of the intervention
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.
Measured: At the time of the intervention
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.
Measured: At the time of the intervention
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.
Measured: At the time of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start15 Aug 2017
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori Erby, Ph.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225170
- Sponsor's protocol ID
- 999917132
- Other IDs
- 17-HG-N132
- Status last verified
- 29 Jun 2020
- First submitted
- 20 Jul 2017
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scherr CL, Christie J, Vadaparampil ST. Breast Cancer Survivors' Knowledge of Hereditary Breast and Ovarian Cancer following Genetic Counseling: An Exploration of General and Survivor-Specific Knowledge Items. Public Health Genomics. 2016;19(1):1-10. doi: 10.1159/000439162. Epub 2015 Sep 22.
PubMed 26389838Kaphingst KA, Facio FM, Cheng MR, Brooks S, Eidem H, Linn A, Biesecker BB, Biesecker LG. Effects of informed consent for individual genome sequencing on relevant knowledge. Clin Genet. 2012 Nov;82(5):408-15. doi: 10.1111/j.1399-0004.2012.01909.x. Epub 2012 Aug 7.
PubMed 22694298Harris PR, Napper L. Self-affirmation and the biased processing of threatening health-risk information. Pers Soc Psychol Bull. 2005 Sep;31(9):1250-63. doi: 10.1177/0146167205274694.
PubMed 16055644Ferrer RA, Klein WM, Graff KA. Self-affirmation increases defensiveness toward health risk information among those experiencing negative emotions: Results from two national samples. Health Psychol. 2017 Apr;36(4):380-391. doi: 10.1037/hea0000460. Epub 2017 Feb 16.
PubMed 28206787
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
- ClinicalTrials.gov ID
- NCT03225170
- Acronym / sponsor ID
- 999917132
- Conditions
- Breast Cancer
- Keywords
- Decision-Making, BRCA1, BRCA2, Genetic Counseling, HBOC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-affirmation (SA) group | Experimental | Behavioral: Self Affirmation (SA)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 | Sham comparator | Behavioral: ControlImmediately 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- -Must be certified GCs who see clients with an indication for HBOC related genetic counseling at St. Luke's Health System
Key exclusion criteria (2 listed)
- Non-English speakers and illiterate subjects will be excluded
- Clients who are unable to provide consent will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self 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. | Behavioural | Self-affirmation (SA) group |
| ControlClients 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. | Behavioural | Control group |
Primary outcome
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
11 secondary outcomes
Mammogram Intention After Counseling: Likelihood of Getting a Mammogram
Time frame: Assessed within one week after completing the genetic counseling session
Client Anxiety After Writing Exercise and Prior to Counseling
Time frame: Assessed immediately after completing the writing exercise and prior to the genetic counseling session
Perceived Effect of Writing Exercise on Genetic Counseling Visit: Number of Clients With Perceived Effect of Intervention After Writing Exercise
Time frame: Assessed within one week after completing the genetic counseling session
Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients
Time frame: Assessed within one week after completing the genetic counseling session
Perception That Intervention Improved Genetic Counseling Visit: Number of Clients
Time frame: Within 1 week after completing the genetic counseling session
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention
Time frame: At the time of the intervention
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value
Time frame: At the time of the intervention
Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing How Value Was Recently Used
Time frame: At the time of the intervention
Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used
Time frame: At the time of the intervention
Level of Engagement With the Writing Exercise: Essay Attitude Strength
Time frame: At the time of the intervention
Level of Engagement With the Writing Exercise: Self-affirmation Score
Time frame: At the time of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26389838Scherr CL, Christie J, Vadaparampil ST. Breast Cancer Survivors' Knowledge of Hereditary Breast and Ovarian Cancer following Genetic Counseling: An Exploration of General and Survivor-Specific Knowledge Items. Public Health Genomics. 2016;19(1):1-10. doi: 10.1159/000439162. Epub 2015 Sep 22.
- Results publication: PubMed 22694298Kaphingst KA, Facio FM, Cheng MR, Brooks S, Eidem H, Linn A, Biesecker BB, Biesecker LG. Effects of informed consent for individual genome sequencing on relevant knowledge. Clin Genet. 2012 Nov;82(5):408-15. doi: 10.1111/j.1399-0004.2012.01909.x. Epub 2012 Aug 7.
- Results publication: PubMed 16055644Harris PR, Napper L. Self-affirmation and the biased processing of threatening health-risk information. Pers Soc Psychol Bull. 2005 Sep;31(9):1250-63. doi: 10.1177/0146167205274694.
- Results publication: PubMed 28206787Ferrer RA, Klein WM, Graff KA. Self-affirmation increases defensiveness toward health risk information among those experiencing negative emotions: Results from two national samples. Health Psychol. 2017 Apr;36(4):380-391. doi: 10.1037/hea0000460. Epub 2017 Feb 16.
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Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Erby, Ph.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Affirmation (SA) in people with Breast Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing (time frame: Assessed within 1 week after completing the genetic counseling session). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03225170, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.