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

January 8, 2025 updated by: schhinnen, Leiden University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Centre
        • Contact:
        • Contact:
        • Contact:
          • Sanne K. de Bie, drs.
        • Contact:
          • Chris Hinnen, dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Cancer Recurrence (FCR)
Time Frame: 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).
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Erasmus Medical Center

Investigators

  • Principal Investigator: Chris Hinnen, Dr., Leiden University Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL79844.058.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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