Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients.

March 27, 2026 updated by: Lega Cancro Ticino

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Loredana Turri, MSc
  • Phone Number: +410918206420

Study Locations

  • Switzerland
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: STANDARD EMDR
Participants receive standard EMDR therapy following the standard EMDR protocol (Shapiro, 2002).
Behavioral: STANDARD EMDR
Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002).
Experimental: EMDR TOOLBOX METHOD
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).
Behavioral: EMDR TOOLBOX METHOD
Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility outcome
Time Frame: 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
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).

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.
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).

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
Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

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
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)

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
From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lega Cancro Ticino

Investigators

  • Principal Investigator: Paola Arnaboldi, Lega Cancro Ticino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-02633

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I am the principal investigator and the sponsor of this study. I will perform statistical analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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