Thyroid NeoplasmsNCT07447089
EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study
A study testing EMDR-IGTP-OTS in people with Thyroid Neoplasms and Neoplasm, run by Università Cattolica di Milano at 1 site in Italy.
Trial summary
The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thyroid Neoplasms, Neoplasm, Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- EMDR-IGTP-OTS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2025to 5 Dec 2026
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer diagnosis
- PTSD (IES-R > 32)
Who cannot join
- receiving specialized trauma therapy
- receiving current psychiatric pharmacological treatment, unless the dosage has been stable for at least 2 months prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore
Milan, 20123
Cesare Cavalera, 3409373408, cesarem.cavalera@unicatt.it
About this study
Official title: Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid Cancer: A Pilot Study
The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.
Read the detailed description
The diagnosis of cancer represents a potentially life-threatening event that can be considered a unique traumatic stressor. A cancer diagnosis can disrupt a person's life, affecting emotions, cognition, and physical pain impacting the individual sense of identity. Findings from the literature suggest that EMDR can be a valid treatment in the processing of cancer-related traumatic events. With this proposal, the investigators aim to evaluate the feasibility and the effects of a combined EMDR Integrative Group Treatment Protocol and an optional EMDR individual protocol for people with cancer.
- Conditions
- Thyroid Neoplasms, Neoplasm, Post-traumatic Stress Disorder (PTSD), Psychological Distress
- Being tested
- EMDR-IGTP-OTS
- Keywords
- Psychoncology, Cancer
- Medical subject headings
- Thyroid Neoplasms, Neoplasms, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR-IGTP-OTSBehavioural
Also called EMDR (classic individual setting)
The intervention follows the EMDR 8-phase protocol as indicated by Jarero et al. (2018). The group sessions use the IGTP-OTS (Integrative Group Treatment Protocol for Ongoing Traumatic Stress) to provide early stabilization.
| Study group | Role | What they receive |
|---|---|---|
| EMDR Treatment Group | Experimental | Participants receive an integrated EMDR intervention consisting of the EMDR Integrative Group Protocol (IGTP-OTS) followed by additional individual EMDR sessions when needed. The treatment focuses on processing traumatic memories related to personal experiences cancer-related. Receives: Behavioral: EMDR-IGTP-OTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale-Revised (IES-R)
Impact of Event Scale-Revised range: The scale is composed by 22 items, each scored 0-4 (Min Score: 0; Max Score: 88).
A higher score indicates a higher intensity of post-traumatic stress symptoms
Measured: Baseline (T1) and Post-intervention (T2, approximately 1 month), Follow-up (T3, approximately 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Dec 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Cattolica di Milano
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo
- Responsible party
- Principal investigator, Cesare Cavalera, Università Cattolica di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447089
- Sponsor's protocol ID
- CET 435-2025
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data, after de-identification, will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
Publications
Quaranta-Leech, A., Zaporozhets, O., Jarero, I., & Holland, D. (2025). Randomized Controlled Trial on the Provision of the EMDR-IGTP-OTS-R for Reduction of Posttraumatic Stress Disorder Symptomology with Mental Health Professionals in Ukraine during the War. Journal of EMDR Practice and Research, 19, 0007.
Jarero, I., Artigas, L., Uribe, S., & García, L. E. (2016). The EMDR integrative group treatment protocol for patients with cancer. Journal of EMDR Practice and Research, 10(3), 199-207.
Jarero, I., Givaudan, M., & Osorio, A. (2018). Randomized controlled trial on the provision of the EMDR integrative group treatment protocol adapted for ongoing traumatic stress to female patients with cancer-related posttraumatic stress disorder symptoms. Journal of EMDR Practice and Research, 12(3), 94-104.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07447089
- Acronym / sponsor ID
- CET 435-2025
- Conditions
- Thyroid Neoplasms, Neoplasm, Post-traumatic Stress Disorder (PTSD), Psychological Distress
- Keywords
- Psychoncology, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Università Cattolica di MilanoUniversity, hospital or other
- Collaborators
- ASST Santi Paolo e Carlo
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 3 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 main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.
Detailed description
The diagnosis of cancer represents a potentially life-threatening event that can be considered a unique traumatic stressor. A cancer diagnosis can disrupt a person's life, affecting emotions, cognition, and physical pain impacting the individual sense of identity. Findings from the literature suggest that EMDR can be a valid treatment in the processing of cancer-related traumatic events. With this proposal, the investigators aim to evaluate the feasibility and the effects of a combined EMDR Integrative Group Treatment Protocol and an optional EMDR individual protocol for people with cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMDR Treatment Group | Experimental | Behavioral: EMDR-IGTP-OTSParticipants receive an integrated EMDR intervention consisting of the EMDR Integrative Group Protocol (IGTP-OTS) followed by additional individual EMDR sessions when needed. The treatment focuses on processing traumatic memories related to personal experiences cancer-related. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cancer diagnosis
- PTSD (IES-R > 32)
Key exclusion criteria (2 listed)
- receiving specialized trauma therapy
- receiving current psychiatric pharmacological treatment, unless the dosage has been stable for at least 2 months prior to enrollment
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 |
|---|---|---|
| EMDR-IGTP-OTSAlso: EMDR (classic individual setting)The intervention follows the EMDR 8-phase protocol as indicated by Jarero et al. (2018). The group sessions use the IGTP-OTS (Integrative Group Treatment Protocol for Ongoing Traumatic Stress) to provide early stabilization. | Behavioural | EMDR Treatment Group |
Primary outcome
Impact of Event Scale-Revised (IES-R)
Time frame: Baseline (T1) and Post-intervention (T2, approximately 1 month), Follow-up (T3, approximately 3 month)
Impact of Event Scale-Revised range: The scale is composed by 22 items, each scored 0-4 (Min Score: 0; Max Score: 88). A higher score indicates a higher intensity of post-traumatic stress symptoms
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 4 Mar 2026.
- BackgroundQuaranta-Leech, A., Zaporozhets, O., Jarero, I., & Holland, D. (2025). Randomized Controlled Trial on the Provision of the EMDR-IGTP-OTS-R for Reduction of Posttraumatic Stress Disorder Symptomology with Mental Health Professionals in Ukraine during the War. Journal of EMDR Practice and Research, 19, 0007.
- BackgroundJarero, I., Artigas, L., Uribe, S., & García, L. E. (2016). The EMDR integrative group treatment protocol for patients with cancer. Journal of EMDR Practice and Research, 10(3), 199-207.
- BackgroundJarero, I., Givaudan, M., & Osorio, A. (2018). Randomized controlled trial on the provision of the EMDR integrative group treatment protocol adapted for ongoing traumatic stress to female patients with cancer-related posttraumatic stress disorder symptoms. Journal of EMDR Practice and Research, 12(3), 94-104.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data, after de-identification, will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR-IGTP-OTS in people with Thyroid Neoplasms and Neoplasm, run by Università Cattolica di Milano at 1 site in Italy.
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 2 inclusion and 2 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Cesare Cavalera (+393409373408, cesarem.cavalera@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Event Scale-Revised (IES-R) (time frame: Baseline (T1) and Post-intervention (T2, approximately 1 month), Follow-up (T3, approximately 3 month)). 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 NCT07447089, which also lists 3 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 4 Mar 2026.