Early implicit promotion of vitality in breast cancer patients during neo-adjuvant treatment.

In the ZGT adherence area, more than 400 women per year are diagnosed with
breast cancer. In addition to surgery and radiotherapy, more than 60% of these
patients receive a form of neoadjuvant or adjuvant system therapy. Many
patients experience high stress levels during and after this multimodality
treatment, which impedes them in picking up or continuing work. One of the main
drivers of stress is cancer-related fatigue (Syrowatka et al., 2017). This is
directly related to restrictions in labor participation (Paalman et al., 2016).
More than 50% of all breast carcinoma patients experience fatigue complaints
during their treatment course, with a substantial proportion retaining serious
fatigue symptoms after the treatment (Fabi et al., 2017). In order to support
women, there are already cancer rehabilitation programs such as "physiofit and
back to balance", in which women qualify during or after completion of
treatment. However, many women do not return to their level of work, such as
before the start of breast cancer treatment. Besides, they are often unable to
fulfill certain social roles as before, because severe fatigue complaints
undermine the necessary physical and mental functioning and make predictability
of participation more difficult. During the treatment process, breast cancer
patients can gradually develop a distorted fatigue self-image (= cognitive
bias). Cognitive bias is unfavorable in relation to fatigue-related behavior
(eg not performing physical activities or interpreting information through
'fatigue goggles') (Crombez et al., 2013; Hughes et al., 2016).

Neoadjuvant treatment programs offer the possibility to offer an early
intervention (eg through eHealth training) already in the preoperative
trajectory. The idea is that early in the treatment process in a low-threshold
and simple way, the distortion in the direction of
fatigue can be reversed and the self-image of the breast cancer patient is
again modified in the direction of vitality. This simple training is called CBM
(= cognitive bias modification) and has already shown beneficial effects in
anxiety, depression, addiction, chronic pain and other symptoms
(Mobini, Reynolds, & Mackintosh, 2013, Grafton et al., 2017, Kakoschke, Kemps,
& Tiggemann, 2017). The underlying theories (dual process models) describe
human behavior and feelings as the integration of deliberate reflexive
processes and automated and unconscious processes. Helpful existing
interventions such as self-management or rehabilitation programs mainly serve
the conscious side of the symptoms and work with the help of health goals and
clarification of steps and behavior to achieve it. The method proposed here
(CBM) intervenes in the automated unconscious processes that determine a large
proportion of health observations and health behavior. The CBM training
consists of an eHealth computer game in which participants have to link
concepts that directly relate to themselves (e.g., I) with words related to
vitality (e.g., energetic). Participants have to link fatigue concepts (e.g.,
exhausted) words not related to the patient (e.g., others). The influence of
this training will be explored by examining the change of implicit or explicit
fatigue and vitality.

By applying a psychological conditioning task (through CBM training), which is
essentially an unconscious process, in addition to the existing guidance
possibilities within ZGT aimed at strengthening conscious processes, we hope to
prevent the occurrence of an unfavorable distortion in the self-image and thus
contribute to maintaining or improving experienced vitality in these patients.
The ultimate goal of the eHealth intervention is that breast cancer patients
experience more restorative capacity and vitality and can therefore deal better
with their illness and treatment. This should result, among other things, in
the fact that more women will be able to return to their original work setting
(rather soon) than without using this technique. To align as much as possible
with the wishes and needs of professionals and patients, investments were made
in a User-Centered Design approach. For this, patients and professionals were
interviewed to gain insight into the phenomenon of fatigue in breast cancer and
how this plays a role in practice. The idea of **CBM is also presented to
patients and professionals and we aim to get an impression of how and when our
CBM intervention can best be presented to patients.

The objective of this study is to test the CBM eHealth app, with regard to the
influence of the app on implicit fatigue self-concept and on explicitly
experienced fatigue and vitality, both immediately after finishing the
two-weekly training. Furthermore, the study aims to explore the acceptance of
the app among the target group. The overall goal of the study is that breast
cancer patients experience more vitality and are better able to cope with their
illness and the treatment.

The current study is a proof-of-concept study in which patients will use the
app for 14 days (for 5 minutes per day). The outcome measures of this study are
implicit fatigue, explicit fatigue, implicit vitality and implicit fatigue. The
implicit measurement of fatigue and vitality consist of the Implicit
Association Test (IAT) on the computer. The explicit measurements consist of
three questionnaires that will be administered on the computer as well: The
Checklist Individual Strengths (CIS), the Dutch vitality questionnaire
(Vita-16) and the depression scale of the Hospital Anxiety and Depression Scale
(HADS). Furthermore, the adherence of the intervention will be administered.
During a short semi-structured interview (max. 30 minutes) after the 14-day
training it will be explored how participants have experienced the use of the
app and if there are point for improvement.

At baseline, the implicit fatigue self-concept will be measured to see what
self-concept patients already have with regard to fatigue, and if this
self-concept is already biased. Furthermore, explicitly experienced fatigue and
vitality will be measured. The first training will take place during the second
chemotherapy session. The reason to have the T0 measurement already before the
first chemo, is to keep this measurement parallel with the T0 measurement of an
ongoing observation study (METC approval already received).

The measurements and the interview will be combined with regular visits to the
hospital.

Overview:
T0: Baseline measurement (before first chemotherapy session)
- Intervention, 14 days training in app - (during second chemotherapy)
T1: Post measurement (after 14 days training in app)

The CBM training consist of an eHealth 'game' in which participants have to
link words related to 'self' (e.g. 'I') to words related to vitality (e.g.
'energetic'). They have to link fatigue related words (e.g. exhausted) to
synonyms to the category 'others' (e.g. 'she').
An example of what the app will look like can be found in the research
protocol.
Participants have to complete the training (5 min.) for 14 consecutive days.

Possibly more fatigue due to 5 min app trainer per day (very low risk)
CBM could have a 'reverse' (not explained in literature yet, risk perceived as
very low)