Clinical trial · Interventional
EMDR for Fear of Cancer Recurrence in Patients with Familial Melanoma: a Waiting List Control Trial
NCT06767332CI-TRIAL-00084517FAMErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Eye Movement Desensitization and Reprocessing | — | UNRESOLVED | — |
| Familial Melanoma | Hereditary Melanoma | ALIAS | 0.90 |
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
| Psychological Intervention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eye movement desensitization and reprocessing (EMDR) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Other: eye movement desensitization and reprocessing (EMDR)
- type
- NO_INTERVENTION
- label
- Waiting-list
- description
- 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.
Primary outcomes (1)
- measure
- Fear of Cancer Recurrence (FCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDHinnen C, Boonstra A, Kukutsch N, van Doorn R. Prevalence and indicators of fear of melanoma in patients with familial melanoma during surveillance. J Eur Acad Dermatol Venereol. 2021 Mar;35(3):e217-e218. doi: 10.1111/jdv.16939. Epub 2020 Oct 1. No abstract available. PMID 32936976
- BACKGROUNDBruin J, van Rood YR, Peeters KCMJ, de Roos C, Tanious R, Portielje JEA, Gelderblom H, Hinnen SCH. Efficacy of eye movement desensitization and reprocessing therapy for fear of cancer recurrence among cancer survivors: a randomized single-case experimental design. Eur J Psychotraumatol. 2023;14(2):2203427. doi: 10.1080/20008066.2023.2203427. PMID 37144665
- BACKGROUNDCusters JA, van den Berg SW, van Laarhoven HW, Bleiker EM, Gielissen MF, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2014 Jan-Feb;37(1):E44-50. doi: 10.1097/NCC.0b013e3182813a17. PMID 23448956
- BACKGROUNDDautovic E, de Roos C, van Rood Y, Dommerholt A, Rodenburg R. Pediatric seizure-related posttraumatic stress and anxiety symptoms treated with EMDR: a case series. Eur J Psychotraumatol. 2016 Jul 4;7:30123. doi: 10.3402/ejpt.v7.30123. eCollection 2016. PMID 27387846
- BACKGROUNDMaroufi M, Zamani S, Izadikhah Z, Marofi M, O'Connor P. Investigating the effect of Eye Movement Desensitization and Reprocessing (EMDR) on postoperative pain intensity in adolescents undergoing surgery: a randomized controlled trial. J Adv Nurs. 2016 Sep;72(9):2207-17. doi: 10.1111/jan.12985. Epub 2016 May 1. PMID 27134066
- BACKGROUNDShapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098. PMID 24626074
- Bell KJL, Mehta Y, Turner RM, Morton RL, Dieng M, Saw R, Guitera P, McCaffery K, Low D, Low C, Jenkins M, Irwig L, Webster AC. Fear of new or recurrent melanoma after treatment for localised melanoma. Psychooncology. 2017 Nov;26(11):1784-1791. doi: 10.1002/pon.4366. Epub 2017 Feb 2.