The aim of this project is to determine optimal communication strategies for prognostic disclosure in the palliative phase of breast cancer from a patient perspective. Study 1: To explore breast cancer survivors*, healthy women*s and oncologists*…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study 1: Qualitative data - opinions concerning the disclosure of a palliative
prognosis and the role of hope and explicitness herein.
Study 2: Experiment: anxiety- and uncertainty reduction
Add-on study: Emotional arousal and recall are the main study parameters of
this pilot study. Emotional arousal will be measured with physiological
responses (heart rate and skin conductance). Recall is assessed as the number
of correctly recognized or recalled information elements (both primed and free
recall) will be measured.
Secondary outcome
Study 2: Experiment: satisfaction, self efficacy
Focusgroups: qualitative data - opinions concerning the specific communication
elements.
Add-on study: same as main study. Extra: positive & negative affect.
Background summary
Good communication is essential in health care, especially in sensitive areas
such as the transition from curative to palliative cancer care. A palliative
breast cancer diagnosis evokes both feelings of uncertainty and anxiety, at
which oncologists have to react. While all patients want to be aware of their
disease*s terminal nature, how explicit versus general oncologist should be in
their prognostic information is still unknown. In addition, the need for hope
persists for all cancer patients, at the same time as the need for realistic
information. But what comprises hope is still unknown and an empirical base for
its beneficial effect is lacking.. So far, experimental studies of
communication in a cancer consultation have not been the focus in much research
for several reasons. First, it is methodologically difficult to create a state
of the art randomized controlled trial in the clinical setting because it is
unethical to expose clinical patients to possibly harmful communication.
Second, communication is often used as a container concept with little focus on
the specific elements it consists of. To overcome these and other problems and
to study the effect of explicit opposed to general prognostic information and
expressed hope opposed to realism on patients* feelings of anxiety and
uncertainty about their future, an experimental study has been created, which
uses healthy subjects and breast cancer survivors instead of clinical patients.
Research also shows that receiving bad news causes stress and patients often do
not remember much of the information provided in bad news consultations.
Therefore an add-on study will be carried out in order whether certain
affective communication can cause a decrease in physiological arousal and
consequently an increase in recall of information provided in a bad news
consultation.
Study objective
The aim of this project is to determine optimal communication strategies for
prognostic disclosure in the palliative phase of breast cancer from a patient
perspective.
Study 1: To explore breast cancer survivors*, healthy women*s and oncologists*
opinions on which topics they consider important when discussing a palliative
prognostic disclosure and how oncologists can trade the fine lines between
providing general as opposed to explicit information and realistic as opposed
to hopeful information when discussing these topics.
Study 2: To determine the main and interaction effects of the levels of
explicitness of information and expressed hope when providing prognostic
disclosure in palliative breast cancer, using a systematic controlled study
design. Mediating and moderating effects of optimism and coping
(monitoring/blunting) will be analyzed.
Add-on study: The objective of this pilot study is to explore in an
experimental design whether various styles of communication in a bad news
consultation have a differential effect on patients* emotional arousal and
recall of provided information. In particular, we want to explore the role of
affective communication.
Study design
Study 1: Focus groups (for breast cancer survivors and healthy subjects) and
semi-structured interviews (for oncologists).
Study 2: Self created, standardized videos in which the level of explicitness
of information and expressed hope are systematically varied will be shown to
healthy subjects and breast cancer survivors to assess the elements* impact on
their perceptions. A subsample of the subjects will participate in focus groups
to provide qualitative information about their opinions concerning the varied
communication elements.
Add-on study: Women will be randomized to watch one out of two videotaped bad
news consultations which are identical in the amount and content of the
provided information but differ in physician*s communication style.
Physiological arousal during watching the video and recall of provided
information will be assessed.
Intervention
Stuy 1: observation-design: focus groups and interviews
Study 2: experiment: 4 video-vignettes are viewed .
Add-on study: 1 video-vignette is viewed.
Study burden and risks
Studie 1 + 2: Breast cancer survivors: It can be a burden for breast cancer
survivors to think about or look at videos of a prognostic disclosure in
palliative cancer care. So, we will only recruit members of the Dutch Breast
Cancer Organisation and have a clinical psychologist available for support.
Healthy women: It can be disturbing for healthy subjects to think about or look
at videos of a prognostic disclosure in palliative cancer care, especially if
they experienced a similar consult in their immediate personal network. No
risk.
Otterstraat 118-124
Postbus 1568, 3500 BN Utrecht
NL
Otterstraat 118-124
Postbus 1568, 3500 BN Utrecht
NL
Listed location countries
Age
Inclusion criteria
Study 1 + 2: breast cancer survivors: women between 18-65, minimally 5 years disease-free, speak fluent Dutch, members of Dutch Breast Cancer Organisation.
healthy women: women between 18 and 65, speak fluent Dutch.
add-on study: healthy women between 18-65, fluent in Dutch
Exclusion criteria
Study 1 + 2: breast cancer survivors: less than 5 years disease free.
healthy women: women who are cancer survivors.;Add-on study: women who are cancer survivors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL29968.041.10 |