Cancer, Psychological Distress
Conditions
Keywords
Cancer, Eye Movement Desensitization and Reprocessing, Psychosomatics, EMDR Toolbox Method, Trauma-focused psychotherapy, Psychotherapy
Brief summary
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
BEHAVIORALSTANDARD EMDR
Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002).
BEHAVIORALEMDR TOOLBOX METHOD
Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).
Sponsors
Lega Cancro Ticino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcome | From randomization (week 0) to post-treatment assessment (approximately 28 weeks). | 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 |
| Change in Overall Psychological Wellbeing as Measured by CORE-OM Total Score | Baseline, 14 weeks (mid-treatment), and 28 weeks (post-treatment). | 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: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) 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. |
| Change in Psychological Symptoms as Measured by CORE-OM Symptoms Subscale | Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28). | 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: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) For this trial comparing Standard EMDR and ETM EMDR, analyses will estimate: * Within-group mean changes over time * Between-group differences in change scores * Effect size estimates (e.g., Cohen's d) with 95% confidence intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Compassion as Measured by the Self-Compassion Scale (SCS) Total Score | Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28). | 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: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) In this trial comparing Standard EMDR and ETM EMDR, analyses will estimate: * within-group mean changes in SCS total score over time * between-group differences in change from baseline- * effect size estimates (e.g., Cohen's d) with 95% confidence intervals |
| Change in Perceived Nighttime Rest Quality as Measured by a Study-Specific Visual Analog Scale (VAS) | From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out) | 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: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) In this trial comparing Standard EMDR and ETM EMDR, analyses will estimate: * Within-group mean change from baseline to post-treatment * Between-group differences in change scores * Effect size estimates (e.g., Cohen's d) with 95% confidence intervals |
Countries
Switzerland
Contacts
CONTACTPaola Arnaboldi, PsyD
CONTACTLoredana Turri, MSc
PRINCIPAL_INVESTIGATORPaola Arnaboldi
Lega Cancro Ticino
Outcome results
None listed