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.
Phase: NA
Conditions: Cancer, Psychological Distress
Sponsor: Lega Cancro Ticino

Version 2, 5/2/2026 
 
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Protocol Title Feasibility and effectiveness of an EMDR psychotherapeutic intervention with additional procedures 
(EMDR Toolbox) in improving psychological well-being in patients diagnosed with oncological disease: a 
randomized study 
Study ID EMDRToolbox_001 
Feasibility and effectiveness of an EMDR psychotherapeutic intervention with additional 
procedures (EMDR Toolbox) in improving psychological well-being in patients diagnosed 
with oncological disease: a randomized study 
 
 
Study Type: 
 Other Clinical Trial according to ClinO, Chapter 4 
 
Risk Categorisation:              Risk category A  
 
Study Registration: 
to be registered on clinicaltrials.gov 
 
Sponsor 
Paola Arnaboldi 
 
c/o Lega cancro Ticino 
 
Piazza Nosetto, 3 
6500 Bellinzona 
T. 091 820 64 20 
E. paola.arnaboldi@legacancro-ti.ch 
 
Principal Investigator 
 Paola Arnaboldi 
 
c/o Lega cancro Ticino 
 
Piazza Nosetto, 3 
6500 Bellinzona 
T. 091 820 64 20 
E. paola.arnaboldi@legacancro-ti.ch 
 
Dipartimento di Scienze Teoriche e Applicate (DiSTA) 
 
 
Università degli Studi eCampus 
 
 
 
 
Via Isimbardi, 10, 22100 Novedrate COMO I 
 
Investigated Intervention: Psicoterapia EMDR secondo le procedure addizionali (EMDR 
Toolbox) (Knipe, 2018; Spadoni, 2026) 
 
Protocol ID 
 
 
EMDRToolbox_001 
Version and Date: 
 
Versione 2 (05/02/2026) 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document is confidential and the property of Paola Arnaboldi (or 
“the sponsor”). The information may not - in full or in part - be transmitted, reproduced, published, 
or disclosed to others than the applicable Competent Ethics Committee and Regulatory 
Authorities) without prior written authorisation from the sponsor except to the extent necessary to 
obtain informed consent from those who will participate in the study. 
 
 

 
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PROTOCOL SIGNATURE FORM    
 
 
Study Title 
Feasibility 
and 
effectiveness 
of 
an 
EMDR 
psychotherapeutic 
intervention 
with 
additional 
procedures 
(EMDR 
Toolbox) 
in 
improving 
psychological well-being in patients diagnosed with 
oncological disease: a randomized study 
Study ID 
EMDRToolbox_001 
 
The Sponsor-Investigator has approved the protocol version 1 (dated 30/11/2025) and confirm 
hereby to conduct the study according to the protocol, current version of the World Medical 
Association Declaration of Helsinki, and ICH-GCP guidelines as well as the local legally 
applicable requirements. 
 
Sponsor: 
 
Name: Paola Arnaboldi 
Date: 
05.02.2026                                    Signature: 
 ___________________________  
 
 
 
 

 
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GLOSSARY OF ABBREVATIONS 
 
AE 
Adverse Event 
BASEC 
Business Administration System for Ethical Committees 
CORE OM 
Clinical Outcomes in Routine Evaluation 
CRF 
Case Report Form 
CTCAE 
Common Terminology Criteria for Adverse Events 
EMDR 
Eye Movement Desensitization and Reprocessing 
FADP 
Federal Act on Data Protection (in German: DSG, in French: LPD, in Italian: LPD) 
eCRF 
electronic Case Report Form 
FOPH 
Federal Office of Public Health 
GCP 
Good Clinical Practice 
HRA 
Human Research Act (in German: HFG, in French: LRH, in Italian: LRUm) 
ICH 
International Conference on Harmonisation  
ClinO 
Ordinance on Clinical Trials in Human Research (in German: KlinV, in French: 
OClin, in Italian: OSRUm) 
SAE 
Serious Adverse Event 
 
 
 
Sponsor / 
Sponsor-
Investigator 
Paola Arnaboldi  
c/o Lega cancro Ticino, Piazza Nosetto 3, 6500 Bellinzona 
T. 091 820 64 20 
E paola.arnaboldi@legacancro-ti.ch 
Study Title 
Feasibility and effectiveness of an EMDR psychotherapeutic 
intervention with additional procedures (EMDR Toolbox) in improving 
psychological well-being in patients diagnosed with oncological 
disease: a randomized study 
Short Title / 
Study ID 
EMDR Toolbox in cancer patients 
Protocol Version 
and Date 
Version 2 (dated 05/02/2026) 
Study 
Registration 
To be registered on clinicaltrials.gov  
Study Category 
and Rationale 
Risk category: A (WHO, 2013) 
Background and 
Rationale  
Given the high prevalence of adverse childhood experiences (ACEs) 
among patients affected by somatic diseases, particularly in oncology, 
it is important to complement the usual triage and psychological 
distress screening interventions provided by psychologists working in 
liaison clinical psychology services with specialized, evidence-based 
psychotherapeutic treatments delivered by trained professionals. 
Among 
the 
range 
of 
currently 
available 
evidence-based 
psychotherapies, Eye Movement Desensitization and Reprocessing 

 
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(EMDR) psychotherapy was recognized by the World Health 
Organization (WHO) in 2013 and again in 2024 as one of the 
treatments of choice for trauma and for the psychophysiological 
consequences of adverse events and stress. 
The standard eight-phase protocol, since its development by the 
American psychologist Francine Shapiro in 1987, has consistently 
represented the primary method for the application of EMDR; however, 
in hospital clinical practice and in liaison psychotherapy outpatient 
settings, difficulties are often encountered in administering standard 
EMDR procedures. These difficulties are often related to the 
complexity of patients’ internal systems. Beginning in the early 1990s, 
the American psychologist Jim Knipe started to present to the EMDR 
community a series of insights aimed at extending the application of 
EMDR to complex patients, that is, individuals with a clinical history 
characterized by multiple stressful life events, as is frequently the case 
for 
patients 
affected 
by 
oncological 
disease 
who 
require 
psychotherapeutic psychological care. 
Subsequently, beginning in 2010, Manuela Spadoni further developed 
Knipe’s insights by creating a toolbox with flashcards designed to 
facilitate the learning of specific EMDR tools (2023). This instrument is 
intended to guide clinicians in the use of a range of additional 
procedures for applying EMDR with complex patients characterized by 
high levels of psychological defenses and dissociative mechanisms. 
From 2015 to the present, Manuela Spadoni has systematized the 
available empirical evidence, theoretical concepts, the parts model, 
and the operational tools developed to date into a structured 
psychotherapeutic method known as the EMDR Toolbox Method 
(ETM) (Spadoni et al., 2026), drawing on Jim Knipe’s 2018 book 
entitled EMDR Toolbox: Theory and Treatment of Complex PTSD and 
Dissociation. 
The present research project represents a first exploratory pilot study 
aimed at investigating the feasibility and effectiveness of an EMDR 
intervention with additional procedures (EMDR Toolbox) (Knipe, 2018; 
Spadoni, 2026) compared with standard EMDR procedures in 
improving emotional well-being in a consecutive sample of patients 
referred to the Clinical Psychology Outpatient Service of the Ticino 
Cancer League by general practitioners, treating specialists, or through 
self-referral.
Risk / Benefit 
Assessment 
It is hypothesized that the present trial will be beneficial for patients 
receiving psychotherapeutic care while affected by a concomitant 
oncological somatic condition. No risks are anticipated in this study. 
Objective(s) 
To assess the feasibility and effectiveness of psychotherapy delivered 
according to additional EMDR procedures (EMDR Toolbox) within the 
Clinical Psychology Outpatient Service of a public-benefit organization, 
the Ticino Cancer League. 
Endpoint(s) 
Primary endpoints: 
- 
Feasibility outcome: completion rate of the 15 psychotherapy 

 
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sessions in the two groups (Toolbox vs. standard). 
- 
Statistically significant difference in the improvement of global 
wellbeing in favor of the group receiving psychotherapy according 
to the additional procedures (EMDR Toolbox). 
- 
Statistically significant difference in the reduction of psychological 
symptoms in favor of the EMDR group using the additional 
procedures (EMDR Toolbox). 
Secondary endpoints: 
- 
Statistically significant difference in the improvement of Self-
Compassion Scale scores in favor of the group receiving EMDR 
Toolbox psychotherapy. This psychological construct underlies 
well-being and a healthy attitude of the individual toward oneself 
(Zessin, 2015). 
- 
Statistically significant difference in perceived sleep quality in favor 
of the group receiving EMDR psychotherapy according to the 
additional procedures. 
 
Since dissociative mechanisms strongly influence the complexity of 
patients’ internal systems and their ability to meta-reflect, thereby 
affecting their capacity to progress in the therapeutic process and 
benefit from it, a normal distribution of dissociative phenomena is 
assumed among the patients enrolled in the study. 
Study Design 
Open-label, parallel-group, randomized controlled trial. 
Inclusion- / 
Exclusion 
Criteria 
Patients diagnosed with cancer who are referred to the Clinical 
Psychology Outpatient Service of the Ticino Cancer League by their 
general practitioner, the treating oncologist, or nurses. Patients who 
self-refer to the service will also be included in the study. 
Inclusion criteria: 
- 
Clinical stage of cancer: stage I, II 
- 
Age 18 to 65 years 
- 
Conditions allowing proper participation in the proposed program 
(ability to complete questionnaires) 
- 
Written informed consent 
Exclusion criteria: 
- 
Psychiatric or other disorders that may prevent the provision of 
informed consent 
Number of 
Participants with 
Rationale 
This is a pilot, exploratory study. A total of 46 patients is expected to 
be enrolled. The sample size calculation is based on the comparison 
of means between independent samples. The most appropriate test is 
a one-tailed Student’s t-test, anticipating a greater effect of EMDR 
Toolbox psychotherapy. The scientific literature on the effectiveness 
of EMDR in cancer patients for reducing PTSD symptoms, as well as 

 
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anxiety and depressive symptoms, reports effect sizes ranging from 
0.5 to 1 (Capezzani et al., 2013; Dimitrov, 2019; Portigliatti Pomeri, 
2021). 
Assuming an effect size of 0.8 in our study, a sample of 42 patients is 
sufficient to detect the expected improvement with a power greater 
than 80%, a type I error rate (alpha) of 5%, using a one-tailed test. 
Assuming a dropout rate of approximately 10–20%, we plan to enroll 
46 patients. The sample size estimate was calculated using G*Power 
3.1 software (Faul et al., 2009).
Study 
Intervention 
The experimental group will receive EMDR psychotherapy according 
to the additional procedures (EMDR Toolbox) (Knipe, 2018; Spadoni, 
2026) over 15 sessions. 
Control 
Intervention 
The control group will receive EMDR treatment according to the 
standard procedures (Shapiro, 2002) over 15 sessions. 
Study 
procedures 
At the time patients are referred to the Clinical Psychology Service of 
the Ticino Cancer League, participation in the study will be offered. 
Upon signing informed consent, they will be assigned to one of the two 
treatment arms (standard EMDR treatment vs. EMDR Toolbox 
treatment). 
At study enrollment (T0), all patients will complete: 
 
A socio-demographic data form 
 
A questionnaire assessing overall psychological well-being 
(CORE-OM, Palmieri, 2006) 
 
A questionnaire assessing self-compassion (Self-Compassion 
Scale, Veneziani, 2017) 
 
The Dissociative Experiences Scale (DES) for evaluating 
dissociative phenomena (Carlson, 1993) 
 
A visual analog scale to assess perceived sleep quality 
Patients in the two groups will undergo psychotherapy according to 
either the additional EMDR procedures (EMDR Toolbox) or standard 
EMDR procedures for 15 sessions. The treatment schedule will be 
adapted to the specific needs of patients with oncological conditions, 
who are often engaged in multiple specialist visits and rehabilitative 
treatments, with a minimum frequency of two sessions per month. 
The 15 sessions represent the basic psychotherapy package covered 
by health insurance in the Swiss Confederation. 
After seven sessions, at mid-treatment (T1), patients will complete: 
 
CORE-SF 
 
Self-Compassion Scale (SCS) 

 
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 
A visual analog scale to assess sleep quality 
The mid-treatment assessment is intended to monitor the progress of 
the variables during the course of therapy.  
Patients will also be asked to report any critical events that have 
occurred since the start of the study in order to control for potential 
confounding variables (e.g., bereavements, separations, recurrence 
diagnoses, treatment complications, or other stressful events). 
At the end of treatment (T2, after 15 sessions), patients will complete: 
 
CORE-SF 
 
Self-Compassion Scale (SCS) 
 
Dissociative Experiences Scale (DES) 
 
A visual analog scale to assess perceived sleep quality 
Aware of the complexity of the psychological phenomena under study, 
it was decided to complement the quantitative data collection with 
qualitative data gathered through in-depth interviews aimed at 
exploring the therapeutic process from the patients’ direct perspective 
after 15 treatment sessions (T2). 
Study Duration 
and Schedule 
Planned 03/2026 of First-Participant-In 
Planned 30/11/2027 of Last-Participant-Out 
Investigator(s) 
Paola Arnaboldi 
Lega cancro Ticino 
Piazza Nosetto 3, 6500 Bellinzona 
T. 091 820 64 20 
E. paola.arnaboldi@legacancro-ti.ch 
Study Center(s) 
Lega cancro Ticino 
Piazza Nosetto 3 
6500 Bellinzona 
T. 091 820 64 20 
Statistical 
Considerations: 
The present research project constitutes the focus of a doctoral thesis 
and has a primarily exploratory aim. It is a pilot study. 
Based on these premises, a statistically significant difference between 
the two groups is expected in CORE-OM scores at the end of the 
intervention, with a medium to large effect size (d). 
The statistical hypothesis to be tested using a one-tailed test is as 
follows: 
H0: μgroup1=μgroup2 
H1: μgroup1≠μgroup2 

 
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To evaluate the comparative effectiveness of the two treatments, post-
treatment (T2) mean scores will be compared between groups using 
an independent samples t-test (or, in the case of repeated measures, 
a repeated measures ANOVA). The test will be one-tailed, as a greater 
improvement is hypothesized a priori in the experimental group 
compared with the control group. 
The level of statistical significance is set at p < 0.05. Prior to analysis, 
assumptions of normality (Shapiro-Wilk test) and homogeneity of 
variances (Levene’s test) will be checked. In case of violations, 
appropriate non-parametric tests will be applied. 
All analyses will be conducted using SPSS version 10. 
Data privacy 
All data collected in the study will be handled in accordance with the 
LPD (2023) and LRUm regulations on personal data protection. 
Participant information will be anonymized at the time of collection and 
stored securely. Patients’ identities will not be disclosed under any 
circumstances, nor will it be possible to trace them in published results. 
Data will be used exclusively for scientific research purposes, with prior 
informed consent from each participant. There will be no transfer of 
data from the research site (Ticino Cancer League) to eCampus 
University. Data will be collected, analyzed, and stored at the same 
site. 
Ethical 
consideration 
This study aims to provide an initial contribution toward generating 
evidence of efficacy for patients undergoing psychotherapy while 
affected by a somatic illness. It seeks to extend the safety and benefit 
principles inherent to the medical discipline to the field of psychology. 
The anticipated benefits are considered to far outweigh the risks, which 
are estimated to be negligible. 
GCP Statement 
This study will be conducted in compliance with the protocol, the 
current version of the Declaration of Helsinki, the ICH-GCP, the HRA 
as well as other locally relevant legal and regulatory requirements.  
 
 
 

 
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