Is it Feasible?: Self-Affirmation for Hereditary Breast and Ovarian Cancer Genetic Counseling
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | June 24, 2019 |
| Contact: | Lori Erby, Ph.D. |
| Email: | lori.erby@nih.gov |
| Phone: | (301) 443-2635 |
Background:
Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is
called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about
tests and treatment. Researchers want to study the best way to guide them. A kind of writing
exercise might help if it is done before genetic counseling. It is called a self-affirmation
(SA) exercise. It may lead to better communication in the counseling and better behavioral
outcomes.
Objective:
To test if an SA exercise done with HBOC genetic counseling could improve client
communication and behavior.
Eligibility:
Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System
Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients
Design:
Appointment participants will be screened by phone.
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:
If they have cancer
If they have had or were offered genetic counseling
Things that are important to them
After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the
office or online. It includes questions about how they felt about the writing exercise and
their counseling.
Counselor participants will take a 2- to 5-minute survey after sessions with clients in the
study. This includes questions about how the client was in the session. They will take a 10-
to 15-minute survey at the end of the study. It will be about their opinions of the writing
exercise.
Some women with breast cancer and ovarian cancer are genetically predisposed to them. This is
called hereditary breast and ovarian cancer (HBOC). The women have to make hard choices about
tests and treatment. Researchers want to study the best way to guide them. A kind of writing
exercise might help if it is done before genetic counseling. It is called a self-affirmation
(SA) exercise. It may lead to better communication in the counseling and better behavioral
outcomes.
Objective:
To test if an SA exercise done with HBOC genetic counseling could improve client
communication and behavior.
Eligibility:
Adults ages 18-90 with an appointment at the HBOC clinic at St. Luke s Health System
Adults ages 18-90 who are genetic counselors with breast and ovarian cancer clients
Design:
Appointment participants will be screened by phone.
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:
If they have cancer
If they have had or were offered genetic counseling
Things that are important to them
After the appointment, they will take a 10- to 15-minute follow-up survey. It can be in the
office or online. It includes questions about how they felt about the writing exercise and
their counseling.
Counselor participants will take a 2- to 5-minute survey after sessions with clients in the
study. This includes questions about how the client was in the session. They will take a 10-
to 15-minute survey at the end of the study. It will be about their opinions of the writing
exercise.
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 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 counselors will be surveyed
after the study 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 by focusing on aspects of subject s 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 of 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.
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 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 counselors will be surveyed
after the study 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 by focusing on aspects of subject s 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 of 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.
- INCLUSION CRITERIA:
- 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.
- Participants must be able to read and write in English to participate.
- Pregnant women will be included.
EXCLUSION CRITERIA:
- Non-English speakers and illiterate subjects will be excluded.
- Clients who are unable to provide consent will be excluded.
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