The implications of discussing uncertainty in cancer genetic counseling about multigene panel testing for (analogue) patients* cognitive and affective outcomes.

Nowadays, multigene panel tests are increasingly used to determine whether
someone has a predisposition for hereditary cancer. These tests involve
sequencing multiple genes at once, including genes whose association with
cancer and consequences are less known. Panel tests are mainly performed when
multiple types of cancer run within family fitting multiple cancer syndromes,
or when a targeted test did not identify a predisposition despite a strong
suspicion. Unfortunately, sequencing increased amounts of (unknown) genes may
increase the level of uncertainty. According to the framework of Han and
colleagues, uncertainty may be scientific, i.e., relating to diagnosis and its
implications, practical, i.e., related to the process of care, or personal,
i.e., related to counselees* psychosocial issues. Informing counselees during
genetic counseling about panel tests unavoidably involves communicating various
forms of uncertainty as uncertainties are part of the information that is
usually provided. With regard to decisions about panel testing, it is
particularly important that counselees are fully informed to enable to make an
informed decision. In addition, communicating uncertainties may also be
beneficial for the relationship between counselor and counselee, and may
enhance counselees* confidence in the counselor. However, previous studies have
shown that the communication of uncertainty may not only be beneficial as it
may overwhelm counselees, cause them to worry, and can even impair their
ability to make decisions. It is unknown what causes the differences in effects
of the communication of uncertainty. One explanation might be that different
manners in which uncertainty is communicated and counselors and counselees deal
with uncertainty during genetic counseling, affect counselees variously.

In a previous study of this research project, we identified uncertainties
expressed by counselors and counselors during oncogenetic counseling. This
study showed that counselors and counselors differ in the uncertainties they
express, and that counselors mainly expressed uncertainty about scientific
topics, while counselees mainly expressed uncertainty about personal and
practical topics (2). Subsequently, in a qualitative study, we investigated the
experiences of counselors and counselees with discussing uncertainty in the
context of panel tests. This study showed, among other things, that counselors
feel uncertain about what they should communicate during pre-test counseling
and that they differ in the degree of uncertainty they communicate to
counselees (3). To gain insight in current practice, we subsequently conducted
an observational study in which counselors conducted a consultation with a
simulated patient (an actor) discussing a panel. Therefore, we gained insight
into the manner and variation in which counselors communicate uncertainty and
their responses to uncertainty expressed by patients. The results of this study
showed that many scientific uncertainties are communicated by counselors and
that they mainly respond to uncertainties expressed by the patient by using
responses that limit the possibility to further discuss this uncertainty (4).
In the current study we want to build upon these results by looking at the
effects of different ways of communicating and responding to uncertainty on
counselees outcomes, such as their level of uncertainty, fear and
understanding. In addition, we want to investigate whether characteristics of
counselees influence the effect of communicating and responding to uncertainty,
on their outcomes.

(1) Han, P.K., Klein, W.M., & Arora, N.K. (2011). Varieties of uncertainty in
health care: a conceptual taxonomy. Medical Decision Making, 31 (6), 828-838.
(2) Medendorp, N. M., Hillen, M.A., Murugesu, L., Aalfs, C.M., Stiggelbout,
A.M., & Smets, E.M. (2018). Uncertainty in consultations about genetic testing
for cancer: an explorative observational study. Patient education and
counseling, 101 (12), 2083-2089.
(3) Medendorp, N. M., Hillen, M.A., Murugesu, L., Aalfs, C.M., Stiggelbout,
A.M., & Smets, E.M. (2018). Uncertainty related to multigene panel testing for
cancer: a qualitative study on counselors 'and counselees' views. Journal of
community genetics, 1-10.
(4) Medendorp, N. M., et al. (2019). "We do not know for sure": The discussion
of uncertainty regarding multigene panel testing during cancer genetic
consultations. (submitted)

This study aims to examine the effects of different manners in which counselors
communicate uncertainty and respond to counselees* uncertainty, on analogue
patients* affective and cognitive outcomes. In addition, the results of this
study are used to make recommendations about how to communicate and respond to
uncertainty in genetic counseling about multigene panel testing, and contribute
to the development of a skills training in communicating and dealing with
uncertainty for genetic counselors.
Research questions:
1. How are different manners of communicating uncertainties (current practice
vs. outline) associated with (analogue) patients* affective and cognitive
outcomes (i.e., level of uncertainty, anxiety, sense of control, satisfaction,
hope, trust in the counselor, confidence in understanding, understanding,
recall, empowerment and decisional conflict)?
2. How are different manners in which counselors respond to counselees*
uncertainties (current practice vs. providing space vs. balancing uncertainty)
associated with (analogue) patients* affective and cognitive outcomes (i.e.,
level of uncertainty, anxiety, sense of control, satisfaction, hope, trust in
the counselor, confidence in understanding, understanding, recall, empowerment
and decisional conflict)?
3. How are combinations of different manners in which counselors communicate
and respond to counselees* uncertainties associated with (analogue) patients*
affective and cognitive outcomes (i.e., level of uncertainty, anxiety, sense of
control, satisfaction, hope, trust in the counselor, confidence in
understanding, understanding, recall, empowerment and decisional conflict)?
4. Do (analogue) patients* sociodemographic characteristics (i.e. age, gender,
educational level, health literacy, medical history and experience with genetic
counseling) and personality characteristics (anxiety, uncertainty tolerance,
optimism, preferences for information, desired role in decision making,
expectation of degree of uncertainty and coping style) moderate the association
between the manner in which uncertainty is communicated and counselors respond
to counselees* uncertainties, and (analogue) patients* affective and cognitive
(i.e., level of uncertainty, anxiety, sense of control, satisfaction, hope,
trust in the counselor, confidence in understanding, understanding, recall,
empowerment and decisional conflict)?

The study involves an experimental video vignettes design using analogue
patients.
Video vignettes are short, scripted video-taped physician-patient
consultations, played by actors. Manipulating oncologists* communicative
behavior in actual clinical practice would not be ethical, because it might
lead to suboptimal communication and adverse patient outcomes. Therefore, a
randomized experimental video-vignettes design was used in this study. Six
versions of a vignette in which a consultation is displayed showing a counselor
and counselee discussing a multigene panel test. The six versions contain the
same content but differ only in specific elements of the communication. This
approach allows us to determine the effect of different communication and
response styles on (analogue) patients* outcomes. Moreover, it allows to
investigate causal relationships between communication and outcomes, as the
communication of counselors is standardized and only small variations are
applied. In this study we will create manipulations regarding how uncertainty
is communicated by counselors, and how they respond to counselees*
uncertainties. One current practice video vignette is developed with the
communication of uncertainty as similar as possible to current practice of
communicating and responding to uncertainty by counselors. One vignette is
developed in addition to the current practice vignette, which is called
outline. The content of the uncertain information that is communicated will be
similar to the current practice vignette, but uncertain information will be
provided to a much lesser extent. With regard to counselors responding to
counselees* uncertainty, two variations in addition to a current practice (i.e.
information provision) vignette are developed. One variation contains responses
by counselors that provide space for the patient to further express his
uncertainties expressed by the patient (e.g. by inviting the patient for
further disclosure) and the second variation contains responses that balance
and emphasize the two sides than uncertainty contains (e.g. that uncertainty
can generate both a negative and positive outcome).
The video vignettes are viewed by so-called analogue patients who will watch
the video while being instructed to imagine themselves being the video patient.
Generally, former patients are used as analogue patients as they have a certain
level of experience with the studied type of consultations.

Burden and risk are estimated as very low. Completing the questionnaire will
only involve a one-off time burden of 45 minutes.