EMDR for Fear of Cancer Recurrence in Patients with Familial Melanoma. A waiting list control trial

There are an estimated 232100 Cutaneous Melanoma (CM) cases diagnosed and 55500
(24%) reported deaths annually.1 The incidence and mortality rates of CM vary
per geographic location and the highest incidence rates are reported for
Caucasian populations with fair skin. Approximately 10% of patients diagnosed
with CM have a positive family history for this malignancy. CDKN2A gene
(p16-leiden mutation) is the major melanoma susceptibility gene explaining
approximately 35% of familial cases. Patients with hereditary melanoma due to a
CDKN2A mutation have an estimated 70% risk of developing melanoma and a 20%
risk of pancreatic cancer. Many patients develop melanoma at an earlier age and
many develop multiple melanomas. Patients with familial melanoma and their
relatives are offered a screening program at the department of dermatology of
the LUMC with regular follow-up visits with a dermatologist to facilitate early
detection and prevention of melanoma from the age of twelve.4 Carriers of a
CDKN2A mutation are additionally screened for pancreatic cancer using MRI from
the age of 40.
Fear of cancer recurrence has been found to be high among patients with CM and
also among patients with familial melanoma (Hinnen, Boonstra, Kukutsch, van
Doorn 2020). A large group of patients indicate they need help with the
uncertainty and threat of developing a new melanoma.5-7 While some amount of
fear may be adaptive and bolster adequate healthcare behaviour such as UV
protection and skin examination, high levels of fear have a negative impact on
patients quality of life8 and may lead to increased healthcare utilization9,10.
EMDR-therapy is a standard treatment for FCR in clinical practise. Till
recently the effectiveness was, however, not scientifically demonstrated. Of
late, we showed that EMDR-therapy was effective in decreasing FCR in patients
with mama- and colorectal carcinoma ( Bruin, van Rood, Peeters, de Roos,
Tanouis, Portielje, Gelderblom & Hinnen, submitted 2021) In this study with a
replicated (n=8) single case experimental design, we found that EMDR had a
large effect on high FCR and that 6 out of 8 patients went from high FCR to low
FCR after EMDR. EMDR is an evidence-based and protocolized treatment for
patients with Post Traumatic Stress Disorder (PTSD) and PTSD symptomatology
including fear of future catastrophes (Balkom van et al., 2013). In most
patients, fear of future catastrophes (illness recurrence or progression) is
based on past experiences. EMDR is an intervention to desensitize both the
memories of past experiences as well as the representations of future
catastrophes. EMDR has been shown effective not only as treatment for PTSD but
also for anxiety in the context of illness or medical situations (Dautovic, de
Roos, van Rood, Dommerholt, & Rodenburg, 2016; van Rood & de Roos, 2009;
Maroufi, Zamani, Izadikhah, Marofi, & O'Connor, 2016).

Primary Objective: The aim of the proposed study is to investigate whether EMDR
is effective in lowering fear of cancer recurrence in patients with familial
Melanoma.

Secondary Objective(s): effectiveness of EMDR and quality of life at 3 months
follow-up (t3)

Baseline characteristics: Marital status, age, gender, educational level,
familial history of melanoma, personal history of melanoma, current disease
status.

In this a non-blinded randomized trial with a waiting list patient high on fear
of cancer recurrence will be included and randomly assigned to an intervention
and waiting-list condition. Those assigned to the intervention condition will
start EMDR-therapy immediately after enrolment. Those assigned to the
waiting-list will start EMDR therapy after 6 weeks when still meeting the
inclusion criteria. Therapy will consist of an intake (90 min) and a maximum of
4 EMDR sessions (90 min each).
After inclusion, baseline characteristic (sociodemographic and clinical
variables) will be assessed. Moreover, before start EMDR, before every session
and 6 weeks and 3 months after ending therapy FCR will be assessed.

EMDR is a psychological intervention that has historically been applied to the
treatment of Post-Traumatic Stress Disorder (PTSD), but has since then been
shown to be effective 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 and 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).
With more than 25 randomized clinical trials, EMDR has been established as an
evidence-based intervention for PTSD and PTSD symptomatology including physical
symptoms and fear of future catastrophes (Balkom van et al., 2013).
Like PTSD, high levels of FCR are associated with intrusive thoughts and
re-experiencing the event, avoidance of reminders of cancer, hypervigilance,
difficulty in making future plans and increased emotional distress (Simonelli
et al, 2017).

In this study 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 4 sessions. The sessions take place in
a face to face appointment at the LUMC Oncology department. The Standard EMDR
protocol is used to desensitize patients* most fearful images of past and
representations of future cancer related catastrophes

Participating in this study will not cause any (physical) harm for the
participants. Participants have to travel to the hospital commit to a limited
amount of sessions (between 2 and 4 depending on the amount of intrusive images
the patient has) of EMDR Primary and secondary outcome measures are filled in
online on a computer or tablet from home. Completion of the questionnaires
(CWS, 4 times during the study, takes about 20 minutes per assessment, may
cause some discomfort because of the time investment.
*