FREE study: investigating the effectiveness of EMDR as a treatment for Fear of Cancer Recurrence among cancer survivors.

In recent years, improved methods of early diagnosis and better treatments of
cancer have led to a growing number of survivors. One of the problems cancer
survivors have to deal with is fear of cancer recurrence (FCR) which is defined
as the *fear, worry, or concern relating to the possibility that cancer will
come back or progresses. While mild or transient FCR has no lasting or serious
consequences , excessive and continuous high FCR is found to impact screening
and follow-up behaviors, mood, relationships, work, goal setting, and quality
of life (QoL) and increase health care costs (Butow et al., 2017).
Previous research has shown that approximately half of cancer survivors and 70%
of more vulnerable groups (eg, young breast cancer survivors) report moderate
to high FCR levels while 10% experience high and disabling FCR (Butow et al.,
2017).
Although excessive FCR has been found to be one of the most common unmet needs,
few studies have investigated treatment options and no consensus exists on the
best management strategies. The few studies that did investigate treatment for
FCR focused on Cognitive Behavioral Therapy. These studies found promising
results, but CBT is time and resource intensive. Therefore, there is need for
treatment options that are of shorter duration and less resource intensive.
A treatment that is already being applied in clinical practice but has yet not
been studied for cancer related fear is Eye Movement Desensitization and
Reprocessing (EMDR).
EMDR is an evidence-based and protocoled treatment for patients with Post
Traumatic Stress Disorder (PTSD) and PTSD symptomatology including fear of
future catastrophes (Shapiro, 2014). In most patients fear of future
catastrophes is based on past experiences. EMDR is a quick, patient and
therapist friendly intervention to desensitize both the memories of past
experiences as well as the representations of future catastrophes. EMDR has
been shown to be effective not only as treatment for PTSD but also as
treatment for a variety of anxiety disorders (e.g. fear of illness and specific
phobia) (Logie & de Jongh, 2014) and somatic complaints such as post-operative
pain, medically unexplained symptoms or seizure-related post-traumatic stress
(Dautovic, de Roos, van Rood, Dommerholt, & Rodenburg, 2016), (van Rood & de
Roos, 2009), (Maroufi, Zamani, Izadikhah, Marofi, & O'Connor, 2016).
The present multiple baseline case series design study will be the first to
investigate whether EMDR may be effective for the treatment of FCR.

The aim of the present study is to investigate the effectiveness of EMDR on
FCR in breast and colon cancer survivors who have high levels of FCR at
baseline. The effect on post-traumatic stress symptoms, quality of life, and
physical symptoms will be explored.
We propose a study combining the results of 10 single-case trials (5 survivors
of mamma carcinoma and 5 survivors of colon carcinoma).

The design used is that of a ten times repeated multiple baseline case series.
The mbcs is a well-established method when investigating the use of
evidence-based psychological treatments in a new contexts. Within the research
group a lot of expertise is available about this specific method. 5 survivors
of mamma carcinoma and 5 survivors of colon carcinoma are randomized for
baseline length (2-6 weeks). After baseline they receive EMDR (2-6 weeks),
followed by a post-treatment period (2-8 weeks). The total length of the study;
i.e. baseline, treatment and post-treatment is 14 weeks and equal for all
patients. After 3 months there is a follow up of 2 weeks.
We hypothesize that EMDR treatment will reduce FCR in cancer survivors and that
the results will be maintained at post-treatment and follow-up.. Furthermore,
the effect on quality of life and physical functioning will be explored.
Combining the results of 10 single-case trials allows for the exploration of
the generality of the effect across subjects and therapists. This type of
research results in preliminary data about the efficacy of the treatment which
can be used to design a Randomized Controlled Trial.

The EMDR intervention consists of one preparation session of 90 minutes
followed by weekly EMDR sessions of 90 minutes. Participants will receive a
minimum of 2 and a maximum of 6 sessions including one preparation session. The
Standard EMDR protocol is used to desensitize patients* most fearful images of
past and representations of future cancer related catastrophes. The intake and
EMDR will be carried out by two trained EMDR Level II therapist.

Participating in this study will not cause any (physical) harm for the
participants. Participants have to travel to the hospital and commit to a
limited amount of sessions (between 2 and 6 depending on the amount of
intrusive images the patient has) of EMDR. There aren't any indications that
EMDR treatment has negative effects, risks or side effects. Some people
experience being more emotionally after EMDR treatment. This is part of the
psychological process and an indicator that the treatment is working. This
emotionality will become less in a couple of days. Er zijn geen nadelige
effecten, risico*s of bijwerkingen te verwachten van de EMDR behandeling of van
het invullen van de vragenlijsten.

Primary and secondary outcome measures are filled in online on a computer or
tablet from home. Answering the 5 questions of the DQ-FCR that form the primary
outcome measure and the 3 items of the DQ-PNF that form one of the secondary
measures takes approximately 2 min per day. Completion of the questionnaires
(CWS, FCRI-NL and 1 item of the EORTC-QLQ-C-30) forming the other secondary
outcome measures, five times during the study, takes about 20 minutes per
assessment. Answering the 8 questions daily and completing the questionnaires
five times may cause some discomfort because of the time investment.