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

Not Applicable

Recruiting

• Conditions: Familial Melanoma; Fear of Cancer Recurrence; Eye Movement Desensitization and Reprocessing; Psychological Intervention

• Registration Number: NCT06767332
• Lead Sponsor: Leiden University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-08-28
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• a score of 16 or higher on the FCRI-NL-SF
• 18 years or older
• diagnosed with familial melanoma

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Exclusion Criteria

• insufficient knowledge of the Dutch language.
• acute psychiatric disease (psychosis, suicidal ideation)
• variable dosis of anxiolytics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fear of Cancer Recurrence (FCR)	EMDR treatment takes approximately 4 weeks, waitinglist 6 weeks. CWS is filled in before randomisation (T0), after 4 weeks/at end of EMDR treatment (T1), after 6 weeks/2 weeks after ending EMDR treatment (T2) and 3 months after ending EMDR treatment (T3)	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).

Secondary Outcome Measures

Name	Time	Method
Quality of life (QoL)	EMDR treatment takes approximately 4 weeks. Waitinglist takes 6 weeks. EORTC-QLQ-C30 is filled in before randomisation (T0), after 6 weeks/2 weeks after ending EMDR treatment (T2) and at follow-up 3 months after ending EMDR treatment (T3).	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).

Trial Locations

Locations (2)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Leiden University Medical Centre; 🇳🇱 Leiden, Zuid-Holland, Netherlands