Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STANDARD EMDR, EMDR TOOLBOX METHOD.
- Who it may be relevant to
- Registry conditions: Cancer, Psychological Distress. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Efficacy of an EMDR Psychotherapeutic Intervention With Additional Procedures (EMDR Toolbox Method) in Improving the Psychological Well-Being of Patients Diagnosed With Oncological Disease: A Randomized Study.
Overview
The incidence of adverse childhood experiences (ACEs) is significantly elevated in patients affected by organic diseases (Riedl, 2020). Adverse childhood experiences include life events such as physical, emotional, and sexual abuse; exposure to domestic violence; abandonment; and physical and emotional neglect occurring during early stages of life. One of the primary and most extensively studied mechanisms through which ACEs appear to influence the development of organic diseases across the lifespan is dysregulation of cortisol levels, which acts as a key mediator of increased macro- and microcellular inflammatory processes. In rhis context, it is important to integrate the standard triage and psychological distress screening interventions routinely provided by psychologists working in clinical liaison psychology services with specialized, evidence-based psychotherapeutic treatments delivered by appropriately trained professionals. Among the range of evidence-based psychotherapies currently available, Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy-hereafter referred to as EMDR-was recognized by the World Health Organization (WHO) in 2013 and reaffirmed in 2024 as one of the treatments of choice for trauma and the psychophysiological consequences of adverse events. Since 2015, Manuela Spadoni has systematized the empirical evidence, theoretical concepts, the parts model, and the operational tools of the additional EMDR procedures introduced by Jim Knipe beginning in 2001 into a structured psychotherapeutic approach known as the EMDR Toolbox method. This method appears to be particularly well suited for treating individuals whose clinical history is characterized by multiple adverse experiences. The present randomized trial aims to evaluate the feasibility and efficacy of the EMDR Toolbox Method (ETM) in patients diagnosed with oncological disease.
Interventions
- Behavioral STANDARD EMDR
Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002). - Behavioral EMDR TOOLBOX METHOD
Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).
Primary outcome measures
- Feasibility outcome [Time frame: From randomization (week 0) to post-treatment assessment (approximately 28 weeks).]
- Change in Overall Psychological Wellbeing as Measured by CORE-OM Total Score [Time frame: Baseline, 14 weeks (mid-treatment), and 28 weeks (post-treatment).]
- Change in Psychological Symptoms as Measured by CORE-OM Symptoms Subscale [Time frame: Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).]
Secondary outcome measures (2)
- Change in Self-Compassion as Measured by the Self-Compassion Scale (SCS) Total Score [Time frame: Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).]
- Change in Perceived Nighttime Rest Quality as Measured by a Study-Specific Visual Analog Scale (VAS) [Time frame: From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out)]
Eligibility criteria
Inclusion criteria
- Clinical stage of the tumor: Stage I, II (TNM classification)
- Age ≥ 18 years <=65
- Conditions enabling correct implementation of the proposed program (ability to complete questionnaires)
- Written informed consent
Exclusion criteria
- Psychiatric or other disorders that may impair the ability to provide informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Switzerland · 2 centers
- Lega cancro Ticino — Bellinzona
- Lega Cancro Ticino — Bellinzona
Publications
- Arnaboldi P, Massari I, Lombardi E, Cavallo M. Prevalence of Personality Disorders in Cancer Patients: A Systematic Literature Review in the Era of Personalized Cancer Care. Cancers (Basel). 2025 Dec 5;17(24):3901. doi: 10.3390/cancers17243901. PMID 41463152
- Portigliatti Pomeri A, La Salvia A, Carletto S, Oliva F, Ostacoli L. EMDR in Cancer Patients: A Systematic Review. Front Psychol. 2021 Jan 18;11:590204. doi: 10.3389/fpsyg.2020.590204. eCollection 2020. PMID 33536968
- Manuela Spadoni, Paola Arnaboldi, Jim Knipe. The EMDR Toolbox Method (ETM): Expanding Jim Knipe's work and Enhancing the AIP Model. J EMDR Pract and Res. 0:DOI:10.34133/jemdr.0027
- Ramallo-Machin A, Gomez-Salas FJ, Burgos-Julian F, Santed-German MA, Gonzalez-Vazquez AI. Factors influencing quality of processing in EMDR therapy. Front Psychol. 2024 Sep 2;15:1432886. doi: 10.3389/fpsyg.2024.1432886. eCollection 2024. PMID 39286565
- Lutgendorf SK, Weinrib AZ, Penedo F, Russell D, DeGeest K, Costanzo ES, Henderson PJ, Sephton SE, Rohleder N, Lucci JA 3rd, Cole S, Sood AK, Lubaroff DM. Interleukin-6, cortisol, and depressive symptoms in ovarian cancer patients. J Clin Oncol. 2008 Oct 10;26(29):4820-7. doi: 10.1200/JCO.2007.14.1978. Epub 2008 Sep 8. PMID 18779606
- Inwood E, Ferrari M. Mechanisms of Change in the Relationship between Self-Compassion, Emotion Regulation, and Mental Health: A Systematic Review. Appl Psychol Health Well Being. 2018 Jul;10(2):215-235. doi: 10.1111/aphw.12127. Epub 2018 Apr 19. PMID 29673093
- Hughes K, Bellis MA, Hardcastle KA, Sethi D, Butchart A, Mikton C, Jones L, Dunne MP. The effect of multiple adverse childhood experiences on health: a systematic review and meta-analysis. Lancet Public Health. 2017 Aug;2(8):e356-e366. doi: 10.1016/S2468-2667(17)30118-4. Epub 2017 Jul 31. PMID 29253477
- Shapiro F, Maxfield L. Eye Movement Desensitization and Reprocessing (EMDR): information processing in the treatment of trauma. J Clin Psychol. 2002 Aug;58(8):933-46. doi: 10.1002/jclp.10068. PMID 12115716
Identifiers
NCT: NCT07481890 · 2025-02633