Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06767332

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

Led by Leiden University Medical Center · Updated on 2025-01-09

30

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

E

Erasmus Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Fear of cancer recurrence (FCR) is a common and distressing issue for patients with familial melanoma, significantly affecting their quality of life. This trial investigates whether Eye Movement Desensitization and Reprocessing (EMDR), a psychological treatment originally used for PTSD and anxiety, can reduce high FCR in these patients. The study compares EMDR to a waiting-list control group in a randomized, non-blinded design. Participants in the intervention group receive an intake session and up to four 90-minute EMDR therapy sessions over approximately four weeks. Those in the waiting-list group wait for six weeks before being offered the same treatment if FCR persists. Assessments occur at baseline, after treatment, and during follow-up periods to measure changes in FCR and quality of life. Throughout the study, participants complete the Cancer Worry Scale (CWS) to evaluate levels of FCR and the EORTC questionnaire to assess quality of life. These evaluations take place before treatment, immediately after, and at two weeks and three months post-treatment. The study aims to track changes in fear and life quality over time, with ongoing monitoring and follow-up as part of the trial process.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A score of 16 or higher on the FCRI-NL-SF
  • 18 years or older
  • Diagnosed with familial melanoma
Not Eligible

You will not qualify if you...

  • Insufficient knowledge of the Dutch language
  • Acute psychiatric disease such as psychosis or suicidal ideation
  • Use of variable dose of anxiolytics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 4 weeks

Participants receive an intake session and up to 4 EMDR therapy sessions to reduce fear of cancer recurrence.

1 intake visit and up to 4 treatment visits (in-person)

Follow-up

Duration - 3 months

Participants are assessed for fear of cancer recurrence and quality of life after treatment at 2 weeks and 3 months.

2 follow-up visits (in-person)

Waiting Period

Duration - 6 weeks

Participants assigned to the waiting list wait for 6 weeks before receiving treatment if needed.

No visits during waiting period

Trial Site Locations

Total: 2 locations

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

2

Leiden University Medical Centre

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

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Research Team

S

Sanne K. de Bie, Drs.

C

Chris Hinnen, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy of eye movement desensitization and reprocessing therapy for fear of cancer recurrence among cancer survivors: a randomized single-case experimental design.

J Bruin, Y R van Rood, K C M J Peeters...

https://pubmed.ncbi.nlm.nih.gov/37144665

Investigating the effect of Eye Movement Desensitization and Reprocessing (EMDR) on postoperative pain intensity in adolescents undergoing surgery: a randomized controlled trial.

Mohsen Maroufi, Shahla Zamani, Zahra Izadikhah...

https://pubmed.ncbi.nlm.nih.gov/27134066

The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences.

Francine Shapiro

https://pubmed.ncbi.nlm.nih.gov/24626074