CancerNCT07481890
Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients.
A study testing STANDARD EMDR and EMDR TOOLBOX METHOD in people with Cancer and Psychological Distress, run by Lega Cancro Ticino at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer, Psychological Distress
- What is being tested?
- STANDARD EMDR and EMDR TOOLBOX METHOD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 27 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric or other disorders that may impair the ability to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Loredana Turri, MSc contact
Switzerland2 sites, 2 recruiting
- Recruiting
Lega cancro Ticino
Bellinzona, Canton Ticino, 6500
Paola Arnaboldi, +41782192859, paola.arnaboldi@legacancro-ti.ch
- Recruiting
Lega Cancro Ticino
Bellinzona, Canton Ticino, 6500
Paola Arnaboldi, MSc, +410918206420, paola.arnaboldi@legacancro-ti.ch
Loredana Turri, MSc
About this study
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.
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.
Read more
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.
- Conditions
- Cancer, Psychological Distress
- Being tested
- STANDARD EMDR, EMDR TOOLBOX METHOD
- Keywords
- Cancer, Eye Movement Desensitization and Reprocessing, Psychosomatics, EMDR Toolbox Method, Trauma-focused psychotherapy, Psychotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARD EMDRBehavioural
Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002).
EMDR TOOLBOX METHODBehavioural
Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).
| Study group | Role | What they receive |
|---|---|---|
| STANDARD EMDR | Active comparator | Participants receive standard EMDR therapy following the standard EMDR protocol (Shapiro, 2002). Receives: Behavioral: STANDARD EMDR |
| 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). Receives: Behavioral: EMDR TOOLBOX METHOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- 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.
Measured: 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:
- 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
Measured: Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).
Secondary outcomes (2)
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:
- 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
Measured: 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:
- 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
Measured: From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start27 Mar 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lega Cancro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Arnaboldi, Principal investigator, Lega Cancro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481890
- Sponsor's protocol ID
- 2025-02633
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I am the principal investigator and the sponsor of this study. I will perform statistical analysis.
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.
PubMed 41463152Portigliatti 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.
PubMed 33536968Manuela 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.
PubMed 39286565Lutgendorf 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.
PubMed 18779606Inwood 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.
PubMed 29673093Hughes 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.
PubMed 29253477Shapiro 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.
PubMed 12115716Shapiro 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.
PubMed 24626074Hinnen 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.
PubMed 38175303Cocchi 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.
PubMed 40989040Carlson 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.
PubMed 8317572Brown 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.
PubMed 23776494Bremner 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.
PubMed 16150669
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07481890
- Acronym / sponsor ID
- 2025-02633
- Conditions
- Cancer, Psychological Distress
- Keywords
- Cancer, Eye Movement Desensitization and Reprocessing, Psychosomatics, EMDR Toolbox Method, Trauma-focused psychotherapy, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Lega Cancro TicinoUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD EMDR | Active comparator | Behavioral: STANDARD EMDRParticipants receive standard EMDR therapy following the standard EMDR protocol (Shapiro, 2002). |
| EMDR TOOLBOX METHOD | Experimental | Behavioral: EMDR TOOLBOX METHODParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Psychiatric or other disorders that may impair the ability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDARD EMDRStandard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002). | Behavioural | STANDARD EMDR |
| EMDR TOOLBOX METHODEye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026). | Behavioural | EMDR TOOLBOX METHOD |
Primary outcome
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
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.
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
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 41463152Arnaboldi 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.
- Background: PubMed 33536968Portigliatti 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.
- BackgroundManuela 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
- Background: PubMed 39286565Ramallo-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.
- Background: PubMed 18779606Lutgendorf 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.
- Background: PubMed 29673093Inwood 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.
- Background: PubMed 29253477Hughes 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.
- Background: PubMed 12115716Shapiro 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.
- Background: PubMed 24626074Shapiro 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.
- Background: PubMed 38175303Hinnen 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.
- Background: PubMed 40989040Cocchi 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.
- Background: PubMed 8317572Carlson 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.
- Individual participant dataSharing planned: No. I am the principal investigator and the sponsor of this study. I will perform statistical analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loredana Turri, MSc contact
Paola Arnaboldi principal investigator
Lega Cancro Ticino
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD EMDR and EMDR TOOLBOX METHOD in people with Cancer and Psychological Distress, run by Lega Cancro Ticino at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Arnaboldi, PsyD (+41782192859, paola.arnaboldi@legacancro-ti.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome (time frame: From randomization (week 0) to post-treatment assessment (approximately 28 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07481890, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.