EMDR for Fear of Cancer Recurrence in Patients with Familial Melanoma: a Waiting List Control Trial

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- a score of 16 or higher on the FCRI-NL-SF.

- 18 years or older.

- diagnosed with familial melanoma.

Exclusion Criteria:

- insufficient knowledge of the Dutch language.

- acute psychiatric disease (psychosis, suicidal ideation) - variable dosis of anxiolytics

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06767332
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Leiden University Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chris Hinnen, Dr.
Principal Investigator Affiliation	Leiden University Medical Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Familial Melanoma, Fear of Cancer Recurrence, Eye Movement Desensitization and Reprocessing, Psychological Intervention

Additional Details

There are an estimated 232100 cutaneous melanoma (CM) cases diagnosed and 55500 (24%) reported deaths worldwide annually. 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 with this type of melanoma develop melanoma at an earlier age than with non-familial melanoma and many develop multiple melanomas. Fear of cancer recurrence (FCR) has been found to be high (38%) among patients with CM and also among patients with familial melanoma. A large group of patients, about one third, indicate they need help with the uncertainty and threat of developing a new melanoma. While some amount of fear may be adaptive and bolster adequate healthcare behavior such as UV protection and skin examination, high levels of fear have a negative impact on patients quality of life and may lead to increased healthcare utilization. In most patients, fear of future catastrophes, such as illness recurrence, is based on past experiences. Eye Movement Desensitization and Reprocessing (EMDR) is an intervention to desensitize both memories of past experiences as well as representations of future catastrophes. EMDR is an evidence-based and protocolized treatment for patients with Post Traumatic Stress Disorder (PTSD) and PTSD symptomatology including fear 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. EMDR is already used in clinical practice as a treatment for FCR. Of late, is shown that EMDR-therapy is effective in decreasing FCR in patients with mammary- and colorectal carcinoma. In this study, with a replicated (n=8) single case experimental design, is 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. In the present study, the investigators will further investigate the effectiveness of EMDR in reducing FCR in patients with familial melanoma. The investigators hypothesize that EMDR treatment will lead to a significant reduction of FCR in comparison to the waitinglist condition at the end of EMDR and at 2 weeks- and 3 months follow-up. The investigators hypothesize that EMDR treatment will improve the quality of life in comparison to the waiting list condition at the end of EMDR and at 2 weeks- and 3 months follow-up.

Arms & Interventions

Arms

Experimental: Intervention

Those assigned to the intervention condition will start EMDR treatment immediately after enrolment. The intervention 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 treatment, after the last EMDR session and 2 weeks- and 3 months after ending EMDR treatment FCR and quality of life will be assessed.

No Intervention: Waiting-list

Those assigned to the waiting-list will wait for 6 weeks. After these 6 weeks those assigned to the waiting list condition are able to receive the same treatment and the same assessment schedule when FCR is still present.

Interventions

Other: - eye movement desensitization and reprocessing (EMDR)

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden, Zuid-Holland, 2333ZA

Site Contact

Sanne Bee

[email protected]

0031 71 526 3615

Leiden University Medical Centre, Leiden, Zuid-Holland, Netherlands

Status

Recruiting

Address

Leiden University Medical Centre

Leiden, Zuid-Holland, 2333ZA

Site Contact

Sanne K. de Bie, drs.

[email protected]

(+31) 071 526 3615

Clinical Trial Finder