Hematologic NeoplasmsTi SentoNCT07861620
Animal-Assisted Intervention for Children With Cancer and Their Siblings
A study testing Dog- and Donkey-Assisted Intervention in people with Hematologic Neoplasms and Neoplasms, run by Azienda Ulss 2 Marca Trevigiana at 1 site in Italy.
Trial summary
This study examined an animal-assisted program for children with hematologic or oncologic disease and their siblings. The program included ten weekly sessions involving dogs and donkeys. Children allocated to the program were compared with children on a waiting list. Read more about this study
- Who is it for?
- Ages 3 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematologic Neoplasms, Neoplasms
- What is being tested?
- Dog- and Donkey-Assisted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2024to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 3 to 25 years.
- Patient with a hematologic or oncologic disease followed by the pediatric hemato-oncology service, or a sibling of such a patient. Siblings did not need to have the disease.
- Clinical suitability for participation in the animal-assisted program, as assessed by the clinical team.
- Informed consent from an adult participant or parent/legal guardian, with age-appropriate assent from minors.
Who cannot join
- Refusal of the animal-assisted intervention.
- Severe immune compromise.
- Signs of infectious illness.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ca' Foncello Hospital, Pediatric Hemato-Oncology Unit, Azienda ULSS 2 Marca Trevigiana
Treviso, Veneto, 31100
About this study
Official title: Ti Sento: A Clinical Study of Affective and Sensory Effects in Patients With Hematologic or Oncologic Disease and Their Siblings Following Animal-Assisted Interventions
This study examined an animal-assisted program for children with hematologic or oncologic disease and their siblings. The program included ten weekly sessions involving dogs and donkeys. Children allocated to the program were compared with children on a waiting list. Assessments were conducted before the program, approximately 15 days after the last session, and approximately two months after the last session. The study assessed children's reported life events, emotional indicators in human figure drawings, family relationships, and parents' coping styles. Waiting-list participants were offered the program after their own final follow-up assessment. This study is being registered retrospectively, after study completion and analysis.
Read the detailed description
The study was conducted through the pediatric hemato-oncology service at Ca' Foncello Hospital in Treviso, Italy. Recruitment took place in two overlapping windows in 2024, January-March and March-April; the second window included new participants only. The intervention, assessment instruments, allocation criteria, and relative assessment schedule were the same in both windows.
Allocation began with a draw of participant codes. Before intervention delivery, the clinical team and study methodologist adjusted some assignments to balance clinical severity, using diagnosis, disease phase, and immune status. Psychological scores were not used for these adjustments. The final allocation was therefore nonrandomized. Patients and siblings could be allocated to different arms within the same household. Waiting-list children did not attend or observe the animal-assisted sessions during the comparison period.
The program was coordinated by a psychologist and psychotherapist trained in animal-assisted interventions, with clinical, animal-handler, and veterinary support. Missed sessions were rescheduled. Drawings were scored with raters masked to allocation and assessment point; participants and intervention personnel were not masked.
Fifty children participated, comprising 30 patients and 20 siblings. Parents completed assessments linked to the participating children; they were not separately enrolled participants.
This record was prepared after study completion and analysis. The investigators report that Koppitz emotional indicators, Coddington life-event scores, and parental CISS coping dimensions had equal priority, without a prospectively documented hierarchy. Their classification as primary outcome measures in this record is retrospective and does not represent prospective registration of a confirmatory analysis plan. The Family Relations Test was an additional exploratory assessment.
- Conditions
- Hematologic Neoplasms, Neoplasms
- Being tested
- Dog- and Donkey-Assisted Intervention
- Keywords
- Animal-Assisted Intervention, Pediatric Oncology, Siblings, Parental Coping, Human Figure Drawing
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog- and Donkey-Assisted InterventionBehavioural
A structured program of ten weekly sessions lasting approximately one hour each: introduction, four dog-assisted sessions, four donkey-assisted sessions, and closure. Activities were coordinated by a psychologist and psychotherapist, with animal handlers and veterinary oversight. Sessions took place at Amici del Cane Ranch in Roncade, Italy, or at home when clinically indicated. Missed sessions were recovered.
| Study group | Role | What they receive |
|---|---|---|
| Animal-Assisted Intervention | Experimental | Ten weekly sessions of approximately one hour, comprising an introductory session, four dog-assisted sessions, four donkey-assisted sessions, and a closing session. Missed sessions were rescheduled. The program was delivered with psychological, clinical, animal-handler, and veterinary support. Receives: Behavioral: Dog- and Donkey-Assisted Intervention |
| Waiting List | No intervention | No participation in or observation of the study animal-assisted sessions during the comparison period. Assessments followed the same relative schedule as in the intervention arm. Participants were offered the animal-assisted program after their own final follow-up assessment; no additional research assessments were conducted during that later program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Life-Event Burden: Coddington Life Events Scales Global Score
Change from baseline in the recorded global score of the Coddington Life Events Scales, using the age-appropriate preschool, child, or adolescent version. Scores are expressed in Life Change Units (LCU), not percentiles. The minimum score is 0. There is no single fixed maximum across versions: the upper score depends on the age-specific item set and any additional events scored. Higher scores indicate greater life-event burden and greater readjustment demands (a less favorable outcome with respect to life-event burden); lower scores indicate less burden. This index measures exposure to life events, not anxiety, quality of life, or a psychiatric diagnosis. A score of 0 denotes a completed questionnaire with no reported events; missing administrations were not coded as 0. Between-arm differences in change were assessed at post-test and follow-up.
Measured: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change in Koppitz Emotional Indicators in Human Figure Drawings
Change from baseline in the mean count of Koppitz emotional indicators across two human figure drawings at each assessment. Thirty indicators were scored for each drawing (count range 0-30); the mean of the two counts also ranges from 0 to 30. Higher values indicate more emotional indicators. Drawings were scored by raters masked to group allocation and assessment time point. Between-arm differences in change were assessed at post-test and follow-up. This is a drawing-based indicator count, not a diagnostic classification.
Measured: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change in Parental Task-Oriented Coping: CISS Raw Score
Change from baseline in the task-oriented coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Measured: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change in Parental Emotion-Oriented Coping: CISS Raw Score
Change from baseline in the emotion-oriented coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Measured: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change in Parental Avoidance Coping: CISS Raw Score
Change from baseline in the avoidance coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Measured: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Jan 2024
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms: animal-assisted intervention and waiting-list comparison. Initial allocation by a draw of participant codes was followed by preintervention clinical adjustments to balance disease severity. Waiting-list participants were offered the intervention after their own final follow-up assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ulss 2 Marca Trevigiana
- Sponsor type
- University, hospital or other
- Collaborators
- GEA ETS - Centro Studi Interventi Assistiti con Animali, AIL - Associazione Italiana contro le Leucemie, Linfomi e Mieloma, Treviso, Istituto Universitario Salesiano Venezia-Mestre (IUS)
- Responsible party
- Principal investigator, Davide Maria Marchioro, Istituto Universitario Salesiano Venezia-Mestre (IUS)
- Investigators
- Cristina Pizzato, MD, Principal investigator, Azienda ULSS 2 Marca Trevigiana, Pediatric Hemato-Oncology Unit, Ca' Foncello Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861620
- Sponsor's protocol ID
- 1122/CE Marca
- Acronym
- Ti Sento
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data supporting the study findings may be shared with researchers on request for research purposes, subject to the applicable consent, privacy, confidentiality, and institutional requirements. Data are not deposited in a publicly accessible repository because of privacy and confidentiality considerations. Access is assessed on request and is not automatic.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ti Sento: A Clinical Study of Affective and Sensory Effects in Patients With Hematologic or Oncologic Disease and Their Siblings Following Animal-Assisted Interventions
- ClinicalTrials.gov ID
- NCT07861620
- Acronym / sponsor ID
- Ti Sento / 1122/CE Marca
- Conditions
- Hematologic Neoplasms, Neoplasms
- Keywords
- Animal-Assisted Intervention, Pediatric Oncology, Siblings, Parental Coping, Human Figure Drawing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ulss 2 Marca TrevigianaUniversity, hospital or other
- Collaborators
- GEA ETS - Centro Studi Interventi Assistiti con Animali, AIL - Associazione Italiana contro le Leucemie, Linfomi e Mieloma, Treviso, Istituto Universitario Salesiano Venezia-Mestre (IUS)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 6 Oct 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.
This study examined an animal-assisted program for children with hematologic or oncologic disease and their siblings. The program included ten weekly sessions involving dogs and donkeys. Children allocated to the program were compared with children on a waiting list. Assessments were conducted before the program, approximately 15 days after the last session, and approximately two months after the last session. The study assessed children's reported life events, emotional indicators in human figure drawings, family relationships, and parents' coping styles. Waiting-list participants were offered the program after their own final follow-up assessment. This study is being registered retrospectively, after study completion and analysis.
Detailed description
The study was conducted through the pediatric hemato-oncology service at Ca' Foncello Hospital in Treviso, Italy. Recruitment took place in two overlapping windows in 2024, January-March and March-April; the second window included new participants only. The intervention, assessment instruments, allocation criteria, and relative assessment schedule were the same in both windows.
Allocation began with a draw of participant codes. Before intervention delivery, the clinical team and study methodologist adjusted some assignments to balance clinical severity, using diagnosis, disease phase, and immune status. Psychological scores were not used for these adjustments. The final allocation was therefore nonrandomized. Patients and siblings could be allocated to different arms within the same household. Waiting-list children did not attend or observe the animal-assisted sessions during the comparison period.
The program was coordinated by a psychologist and psychotherapist trained in animal-assisted interventions, with clinical, animal-handler, and veterinary support. Missed sessions were rescheduled. Drawings were scored with raters masked to allocation and assessment point; participants and intervention personnel were not masked.
Fifty children participated, comprising 30 patients and 20 siblings. Parents completed assessments linked to the participating children; they were not separately enrolled participants.
This record was prepared after study completion and analysis. The investigators report that Koppitz emotional indicators, Coddington life-event scores, and parental CISS coping dimensions had equal priority, without a prospectively documented hierarchy. Their classification as primary outcome measures in this record is retrospective and does not represent prospective registration of a confirmatory analysis plan. The Family Relations Test was an additional exploratory assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms: animal-assisted intervention and waiting-list comparison. Initial allocation by a draw of participant codes was followed by preintervention clinical adjustments to balance disease severity. Waiting-list participants were offered the intervention after their own final follow-up assessment.
| Arm | Type | Receives |
|---|---|---|
| Animal-Assisted Intervention | Experimental | Behavioral: Dog- and Donkey-Assisted InterventionTen weekly sessions of approximately one hour, comprising an introductory session, four dog-assisted sessions, four donkey-assisted sessions, and a closing session. Missed sessions were rescheduled. The program was delivered with psychological, clinical, animal-handler, and veterinary support. |
| Waiting List | No intervention | –No participation in or observation of the study animal-assisted sessions during the comparison period. Assessments followed the same relative schedule as in the intervention arm. Participants were offered the animal-assisted program after their own final follow-up assessment; no additional research assessments were conducted during that later program. |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 3 to 25 years.
- Patient with a hematologic or oncologic disease followed by the pediatric hemato-oncology service, or a sibling of such a patient. Siblings did not need to have the disease.
- Clinical suitability for participation in the animal-assisted program, as assessed by the clinical team.
- Informed consent from an adult participant or parent/legal guardian, with age-appropriate assent from minors.
Key exclusion criteria (3 listed)
- Refusal of the animal-assisted intervention.
- Severe immune compromise.
- Signs of infectious illness.
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 |
|---|---|---|
| Dog- and Donkey-Assisted InterventionA structured program of ten weekly sessions lasting approximately one hour each: introduction, four dog-assisted sessions, four donkey-assisted sessions, and closure. Activities were coordinated by a psychologist and psychotherapist, with animal handlers and veterinary oversight. Sessions took place at Amici del Cane Ranch in Roncade, Italy, or at home when clinically indicated. Missed sessions were recovered. | Behavioural | Animal-Assisted Intervention |
Primary outcome
Change in Life-Event Burden: Coddington Life Events Scales Global Score
Time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change from baseline in the recorded global score of the Coddington Life Events Scales, using the age-appropriate preschool, child, or adolescent version. Scores are expressed in Life Change Units (LCU), not percentiles. The minimum score is 0. There is no single fixed maximum across versions: the upper score depends on the age-specific item set and any additional events scored. Higher scores indicate greater life-event burden and greater readjustment demands (a less favorable outcome with respect to life-event burden); lower scores indicate less burden. This index measures exposure to life events, not anxiety, quality of life, or a psychiatric diagnosis. A score of 0 denotes a completed questionnaire with no reported events; missing administrations were not coded as 0. Between-arm differences in change were assessed at post-test and follow-up.
Change in Koppitz Emotional Indicators in Human Figure Drawings
Time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change from baseline in the mean count of Koppitz emotional indicators across two human figure drawings at each assessment. Thirty indicators were scored for each drawing (count range 0-30); the mean of the two counts also ranges from 0 to 30. Higher values indicate more emotional indicators. Drawings were scored by raters masked to group allocation and assessment time point. Between-arm differences in change were assessed at post-test and follow-up. This is a drawing-based indicator count, not a diagnostic classification.
Change in Parental Task-Oriented Coping: CISS Raw Score
Time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change from baseline in the task-oriented coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Change in Parental Emotion-Oriented Coping: CISS Raw Score
Time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change from baseline in the emotion-oriented coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Change in Parental Avoidance Coping: CISS Raw Score
Time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.
Change from baseline in the avoidance coping scale of the Coping Inventory for Stressful Situations (CISS), Italian adaptation (2010), completed by parents in relation to their own coping styles. The scale contains 16 items scored from 1 to 5, giving a raw score from 16 to 80. Higher scores indicate greater use of this coping style, not necessarily better or worse functioning. Between-arm differences in change were assessed using the allocation of the child linked to each parental record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data supporting the study findings may be shared with researchers on request for research purposes, subject to the applicable consent, privacy, confidentiality, and institutional requirements. Data are not deposited in a publicly accessible repository because of privacy and confidentiality considerations. Access is assessed on request and is not automatic.
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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. This study is not recruiting at the moment.
Cristina Pizzato, MD principal investigator
Azienda ULSS 2 Marca Trevigiana, Pediatric Hemato-Oncology Unit, Ca' Foncello Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog- and Donkey-Assisted Intervention in people with Hematologic Neoplasms and Neoplasms, run by Azienda Ulss 2 Marca Trevigiana 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Life-Event Burden: Coddington Life Events Scales Global Score (time frame: Baseline; approximately 15 days after the last session of the 10-week program; approximately two months after the last session.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.