Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARD EMDR | Active Comparator | Participants receive standard EMDR therapy following the standard EMDR protocol (Shapiro, 2002). |
|
| EMDR TOOLBOX METHOD | Experimental | Participants receive EMDR therapy using the EMDR Toolbox Method including the Ovals Tool as a case formulation tool and additional tools tools such as Loving Eyes (LE) and Constant Installation of Present Orientation and Safety (CIPOS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STANDARD EMDR | Behavioral | Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcome | Feasibility will be evaluated in this pilot randomized controlled trial comparing Standard EMDR and EMDR Toolbox Method delivered over 15 sessions. Feasibility indicators will include: - Treatment adherence (proportion of participants attending at least 10 out of 15 sessions) Feasibility criteria will be considered met if: - ≥65% of randomized participants complete at least 10 out of 15 sessions | From randomization (week 0) to post-treatment assessment (approximately 28 weeks). |
| Change in Overall Psychological Wellbeing as Measured by CORE-OM Total Score | Overall psychological wellbeing will be assessed using the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) total score [range score: 0-136]. The CORE-OM is a self-report measure of global psychological distress and functioning, with higher scores indicating greater psychological distress. Assessments will be conducted at three time points:
The primary analysis for this pilot study will estimate within-group and between-group mean changes in CORE-OM total scores over time. Effect size estimates (e.g., Cohen's d) and 95% confidence intervals will be calculated to inform the design and sample size estimation of a future definitive trial. | Baseline, 14 weeks (mid-treatment), and 28 weeks (post-treatment). |
| Change in Psychological Symptoms as Measured by CORE-OM Symptoms Subscale | Psychological symptoms will be assessed using the Symptoms subscale of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) [range score: 0-48]. The Symptoms domain evaluates the severity of psychological distress, including anxiety, depression, trauma-related and somatic symptoms. Higher scores indicate greater symptom severity. Assessments will be conducted at three time points:
For this trial comparing Standard EMDR and ETM EMDR, analyses will estimate:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Compassion as Measured by the Self-Compassion Scale (SCS) Total Score | Self-compassion will be assessed using the Self-Compassion Scale (SCS), a validated self-report measure evaluating levels of self-kindness, common humanity, and mindfulness versus self-judgment, isolation, and over-identification [range score: 26-130]. Higher total scores indicate greater self-compassion. This psychological construct is fundamental to well-being and to a healthy attitude toward oneself (Zessin, 2015). Assessments will be conducted at three time points:
In this trial comparing Standard EMDR and ETM EMDR, analyses will estimate:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Arnaboldi, PsyD | Contact | +41782192859 | paola.arnaboldi@legacancro-ti.ch | |
| Loredana Turri, MSc | Contact | +410918206420 |
| Name | Affiliation | Role |
|---|---|---|
| Paola Arnaboldi | Lega Cancro Ticino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lega cancro Ticino | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41463152 | Background | 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. | |
| 33536968 | Background | 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. |
Not provided
Not provided
I am the principal investigator and the sponsor of this study. I will perform statistical analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2026 | Mar 8, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EMDR TOOLBOX METHOD | Behavioral | Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026). |
|
| Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28). |
| 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) | Perceived quality of nighttime rest will be assessed using a study-specific Visual Analog Scale (VAS) ranging from 0 to 10. Participants will be asked to rate their overall perceived quality of sleep over the past week, where 0 indicates "very poor quality of rest" and 10 indicates "excellent quality of rest." Higher scores reflect better perceived sleep quality. Assessments will be conducted at two time points:
In this trial comparing Standard EMDR and ETM EMDR, analyses will estimate:
| From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out) |
| Lega Cancro Ticino | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
|
| Background | 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 |
| 39286565 | Background | 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. |
| 18779606 | Background | 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. |
| 29673093 | Background | 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. |
| 29253477 | Background | 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. |
| 12115716 | Background | 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. |
| 24626074 | 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. |
| 38175303 | Background | Hinnen C, von Haeseler E, Tijssens F, Mols F. Adverse childhood events and mental health problems in cancer survivors: a systematic review. Support Care Cancer. 2024 Jan 4;32(1):80. doi: 10.1007/s00520-023-08280-7. |
| 40989040 | Background | Cocchi M, Girone N, Leonardi M, Achilli F, Benatti B, dell'Osso B. Evaluation of Adherence to Pharmacological Treatment in a Large Sample of Patients with Personality Disorder. Clin Neuropsychiatry. 2025 Aug;22(4):279-286. doi: 10.36131/cnfioritieditore20250402. |
| 8317572 | Background | Carlson EB, Putnam FW, Ross CA, Torem M, Coons P, Dill DL, Loewenstein RJ, Braun BG. Validity of the Dissociative Experiences Scale in screening for multiple personality disorder: a multicenter study. Am J Psychiatry. 1993 Jul;150(7):1030-6. doi: 10.1176/ajp.150.7.1030. |
| 23776494 | Background | Brown MJ, Thacker LR, Cohen SA. Association between adverse childhood experiences and diagnosis of cancer. PLoS One. 2013 Jun 11;8(6):e65524. doi: 10.1371/journal.pone.0065524. Print 2013. |
| 16150669 | Background | Bremner JD. Effects of traumatic stress on brain structure and function: relevance to early responses to trauma. J Trauma Dissociation. 2005;6(2):51-68. doi: 10.1300/J229v06n02_06. |