Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Decision Self-efficacy: Ability to Confidently Make Decision About Genetic Testing
时间窗: 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
Test Uptake: Number of Clients Who Indicated Intention to Have Genetic Testing
时间窗: 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
Likelihood of Talking With Family Members
时间窗: 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
Client Knowledge: Hereditary Breast and Ovarian Cancer (HBOC) Knowledge Post Counselling Session
时间窗: 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.
Number of Clients Who Indicated "Intention to Talk With Family" About Genetic Testing Result
时间窗: 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)?"
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)
时间窗: 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)
时间窗: 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
次要结局
- Perception That Writing Exercise Hindered Genetic Counseling Visit: Number of Clients(Assessed within one week after completing the genetic counseling session)
- 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)
- Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention Discussing Importance of Selected Value(At the time of the intervention)
- Level of Engagement With the Writing Exercise: Number of Examples of How Value Was Recently Used(At the time of the intervention)
- Level of Engagement With the Writing Exercise: Number of Words in Writing Intervention(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(At the time of the intervention)
- Perception That Intervention Improved Genetic Counseling Visit: Number of Clients(Within 1 week after completing the genetic counseling session)
- Level of Engagement With the Writing Exercise: Essay Attitude Strength(At the time of the intervention)
- Mammogram Intention After Counseling: Likelihood of Getting a Mammogram(Assessed within one week after completing the genetic counseling session)
- Client Anxiety After Writing Exercise and Prior to Counseling(Assessed immediately after completing the writing exercise and prior to the genetic counseling session)
- Level of Engagement With the Writing Exercise: Self-affirmation Score(At the time of the intervention)