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

NCT06767332 | Recruiting DMC

• 1 other identifier: NL79844.058.22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

EMDR; Fear of Cancer Recurrence; Familial Melanoma; Eye Movement Desensitization and Reprocessing; Psychological intervention; Anxiety; Psycho-oncology; FCR

Outcome Measures

Primary Outcomes (1)

• Fear of Cancer Recurrence (FCR)

  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 Outcomes (1)

• 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).

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Waiting-list

NO INTERVENTION

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

eye movement desensitization and reprocessing (EMDR) OTHER

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Erasmus Medical Center: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Leiden University Medical Centre

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Related Publications (15)

• Hinnen 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 BACKGROUND

• Bruin 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 BACKGROUND

• Custers 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 BACKGROUND

• Dautovic 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 BACKGROUND

• Maroufi 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 BACKGROUND

• Shapiro 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 BACKGROUND

• 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.

  PMID: 28052599 BACKGROUND

• Champagne A, Ivers H, Savard J. Utilization of health care services in cancer patients with elevated fear of cancer recurrence. Psychooncology. 2018 Aug;27(8):1958-1964. doi: 10.1002/pon.4748. Epub 2018 Jun 1.

  PMID: 29719072 BACKGROUND

• Fischbeck S, Imruck BH, Blettner M, Weyer V, Binder H, Zeissig SR, Emrich K, Friedrich-Mai P, Beutel ME. Psychosocial Care Needs of Melanoma Survivors: Are They Being Met? PLoS One. 2015 Aug 21;10(8):e0132754. doi: 10.1371/journal.pone.0132754. eCollection 2015.

  PMID: 26296089 BACKGROUND

• Halk AB, Potjer TP, Kukutsch NA, Vasen HFA, Hes FJ, van Doorn R. Surveillance for familial melanoma: recommendations from a national centre of expertise. Br J Dermatol. 2019 Sep;181(3):594-596. doi: 10.1111/bjd.17767. Epub 2019 May 1. No abstract available.

  PMID: 30742720 BACKGROUND

• Kasparian NA, McLoone JK, Butow PN. Psychological responses and coping strategies among patients with malignant melanoma: a systematic review of the literature. Arch Dermatol. 2009 Dec;145(12):1415-27. doi: 10.1001/archdermatol.2009.308.

  PMID: 20026852 BACKGROUND

• Otto AK, Soriano EC, Siegel SD, LoSavio ST, Laurenceau JP. Assessing the relationship between fear of cancer recurrence and health care utilization in early-stage breast cancer survivors. J Cancer Surviv. 2018 Dec;12(6):775-785. doi: 10.1007/s11764-018-0714-8. Epub 2018 Oct 19.

  PMID: 30341560 BACKGROUND

• Schadendorf D, van Akkooi ACJ, Berking C, Griewank KG, Gutzmer R, Hauschild A, Stang A, Roesch A, Ugurel S. Melanoma. Lancet. 2018 Sep 15;392(10151):971-984. doi: 10.1016/S0140-6736(18)31559-9.

  PMID: 30238891 BACKGROUND

• Smith AB, Costa D, Galica J, Lebel S, Tauber N, van Helmondt SJ, Zachariae R. Spotlight on the Fear of Cancer Recurrence Inventory (FCRI). Psychol Res Behav Manag. 2020 Dec 21;13:1257-1268. doi: 10.2147/PRBM.S231577. eCollection 2020.

  PMID: 33376421 BACKGROUND

• Wagner T, Augustin M, Blome C, Forschner A, Garbe C, Gutzmer R, Hauschild A, Heinzerling L, Livingstone E, Loquai C, Schadendorf D, Terheyden P, Mueller-Brenne T, Kahler KC. Fear of cancer progression in patients with stage IA malignant melanoma. Eur J Cancer Care (Engl). 2018 Sep;27(5):e12901. doi: 10.1111/ecc.12901. Epub 2018 Aug 20.

  PMID: 30126009 BACKGROUND

MeSH Terms

Conditions

Melanoma, Cutaneous Malignant; Anxiety Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chris Hinnen, Dr.

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne K. de Bie, Drs.

CONTACT

0031 71 526 3615; s.k.de_bie@lumc.nl

Chris Hinnen, Dr.

CONTACT

0031 71 526 3615; s.c.h.hinnen@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Chris (S.C.H.) Hinnen, Principal Investigator, Clinical Psychologist

Model Details: Randomised waiting-list controlled trial

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: January 9, 2025
• Study Start: November 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)