High fear of cancer recurrence (FCR) impacts patient's quality of life (QoL) and is prevalent among patients with familial melanoma. The main objective is to investigate whether EMDR is effective in treating high FCR in patients with familial melanoma. The study design is a non-blinded, randomized waiting-list controlled trial. Patients aged 18 years or older with familial melanoma can be included. Patients with high FCR will receive a maximum of 4, 90 minutes, EMDR-sessions. The main study parameter is the decrease and level of FCR measured with the Cancer Worry Scale (CWS). The secondary study parameter is quality of life, measured with the EORTC.
a score of 16 or higher on the FCRI-NL-SF
18 years or older
diagnosed with familial melanoma
insufficient knowledge of the Dutch language.
acute psychiatric disease (psychosis, suicidal ideation)
variable dosis of anxiolytics
Parallel
eye movement desensitization and reprocessing (EMDR)
Other interventionEMDR 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).
Fear of Cancer Recurrence (FCR)
FCR is measured with de Cancer Worry Scale (CWS). The CWS is able to detect high levels of FCR in a 6-item questionnaire (a 4 point Likert scale Ranging from 1 ("never") to 4 ("almost always"). Possible scores range from 6 to 24 with higher scores indicating more worry. The CWS is a much used and reliable and valid questionnaire to assess FCR in cancer survivors (Custers, et al., 2014).
Quality of life (QoL)
QoL is measured with the EORTC-QLQ-C30. The EORTC-QLQ-C30 has been developed for measuring health related quality of life in cancer patients (Aaronson, et al., 1993). The self-report questionnaire consists of 30 items of which 28 items are scored on a 4 points likert-scale and 2 items are scored on a 7 points likert-scale. The questionnaire contains functional and symptom subscales, and two items assessing general quality of life. The EORTC-QLQ-C30 is found to be reliable and valid for measuring the quality of life (Aaronson, et al., 1993, Groenvold, et al., 1997). The most recent version (3.0) has been tested in EORTC field studies (Bjordal, et al., 2000).
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Leiden University Medical Center
Lead sponsor
Erasmus Medical Center
Collaborator
