Pediatric CancerCopAtNCT06858163
Coping and Attachment in Pediatric Oncohematology
An observational study of Pediatric Cancer and Coping Behavior, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 sites in Italy.
Trial summary
Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer, Coping Behavior, Relationship, Parent Child
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 12 Jul 2023to 31 Dec 2026
- Phase
- Observational
- 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parents (single/father and mother) of patients in care of Pediatric Oncohematology departments who meet the inclusion criteria and pediatric patients in treatment at the Pediatric Oncohematology departments who meet the inclusion criteria.
Parents Inclusion Criteria:
- parents of both sexes
- age of son/daughter between 8 and 17 years old (included)
- son/daughter being treated at the Pediatric Oncohematology departments involved in the research (Day Hospital and hospitalization)
- good understanding of the Italian language
Parents Exclusion Criteria:
● son/daughter in off-therapy
Patients Inclusion Criteria:
- age between 8 and 17 years old (included), undergoing treatment at the Pediatric Oncohematology departments (Day Hospital and hospitalization)
- parents enrolled in the study
- good understanding of the Italian language
Patients Exclusion Criteria:
● patients in off-therapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Ospedale San Gerardo, SC Ematologia Pediatrica
Monza, Monza-Brianza, 20900
- Recruiting
SC Ematologia 2 - Oncoematologia pediatrica
Pavia, Pavia, 27100
Marco Zecca, MD, +390382501258, m.zecca@smatteo.pv.it
- Recruiting
Struttura Complessa di Pediatria e Oncoematologia Pediatrica, Ospedale SS Annunziata
Taranto, Taranto, 74100
Maria Montanaro
About this study
Official title: Coping and Attachment in Pediatric Oncohematology: Multicenter Cross-sectional Study to Assess Emotional Resources and Attachment Dynamics Related to Coping Strategies in Parents of Children With Oncohematologic Disease
Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child.
Despite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. Coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations.
Read more
Currently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. The former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution/alteration (e.g., problem identification and resolution, stress cause research). Some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment.
The clinical experience with patients in the Pediatric Oncohematology Department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed.
The research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents cohort | Father and mother of each patient in care at the Pediatric Oncohematology department and enrolled in the study. The correlation between attachment dynamics and emotional care resources related to coping strategies will be assessed. Administration of psychological tests will take place one time after the enrollment in the study. | |
| Patients cohort | Pediatric patients in care at the Pediatric Oncohematology department. Administration of psychological tests will take place one time after the enrollment in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-Parent Relationship Scale
Child-Parent Relationship Scale is a 30-item, self-report instrument used to assess conflict and relational closeness, two important aspects in the emotional support provided to the child and compliance with care, as well as perceived parental distress. The Likert scale ranges from 1 to 5, where 1 stands for "Absolutely not true" and 5 stands for "Definitely true." Scoring is done by summing the raw scores of the items in the three sections (positive aspects of the relationship, conflict and dependence) divided by the items in each sub-scale (mean score).
Measured: One time just after the enrollment
Coping Orientations to Problem Experienced
"Coping Orientations to Problem Experienced- New Italian Version" is a self-report questionnaire that considers different coping modes. The Likert scale ranges from 1 to 4, where 1 stands for "I usually don't do it" and 4 stands for "I almost always do it." The instrument consists of 60 items, divided into 5 independent dimensions: social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation. The scores from 1 to 4 are based on the responses identified by the subject for each item except for 4 "reverse" responses (items 8-20-36-50) for which the chosen score must be reversed. The items are then divided into groups for the identification of the 5 coping factors (social support, avoidance, positive attitude and transcendent orientation). Higher scores indicate greater use of that specific coping strategy.
Measured: One time just after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start12 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 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 Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Soleterre - Strategie di Pace ONLUS, University of Pavia, Catholic University of the Sacred Heart
- Responsible party
- Principal investigator, Marco Zecca, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858163
- Sponsor's protocol ID
- CopAt
- Acronym
- CopAt
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lazarus, R. S., and Folkman, S. (1984). Stress, Appraisal and Coping. New York, NY: Springer.
Sica, C., Magni, C., Ghisi, M., Altoè, G., Sighinolfi, C., Chiri, L. R., & Franceschini, S. (2008). Coping Orientation to Problems Experienced-Nuova Versione Italiana (COPE-NVI): uno strumento per la misura degli stili di coping. Psicoterapia cognitiva e comportamentale, 14(1), 27.
Monti JD, Winning A, Watson KH, Williams EK, Gerhardt CA, Compas BE, Vannatta K. Maternal and Paternal Influences on Children's Coping with Cancer-Related Stress. J Child Fam Stud. 2017 Jul;26(7):2016-2025. doi: 10.1007/s10826-017-0711-y. Epub 2017 Apr 17.
PubMed 29056838
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping and Attachment in Pediatric Oncohematology: Multicenter Cross-sectional Study to Assess Emotional Resources and Attachment Dynamics Related to Coping Strategies in Parents of Children With Oncohematologic Disease
- ClinicalTrials.gov ID
- NCT06858163
- Acronym / sponsor ID
- CopAt / CopAt
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Fondazione Soleterre - Strategie di Pace ONLUS, University of Pavia, Catholic University of the Sacred Heart
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child.
Despite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. Coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations.
Currently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. The former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution/alteration (e.g., problem identification and resolution, stress cause research). Some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment.
The clinical experience with patients in the Pediatric Oncohematology Department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed.
The research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents cohort | – | –Father and mother of each patient in care at the Pediatric Oncohematology department and enrolled in the study. The correlation between attachment dynamics and emotional care resources related to coping strategies will be assessed. Administration of psychological tests will take place one time after the enrollment in the study. |
| Patients cohort | – | –Pediatric patients in care at the Pediatric Oncohematology department. Administration of psychological tests will take place one time after the enrollment in the study. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parents (single/father and mother) of patients in care of Pediatric Oncohematology departments who meet the inclusion criteria and pediatric patients in treatment at the Pediatric Oncohematology departments who meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child-Parent Relationship Scale
Time frame: One time just after the enrollment
Child-Parent Relationship Scale is a 30-item, self-report instrument used to assess conflict and relational closeness, two important aspects in the emotional support provided to the child and compliance with care, as well as perceived parental distress. The Likert scale ranges from 1 to 5, where 1 stands for "Absolutely not true" and 5 stands for "Definitely true." Scoring is done by summing the raw scores of the items in the three sections (positive aspects of the relationship, conflict and dependence) divided by the items in each sub-scale (mean score).
Coping Orientations to Problem Experienced
Time frame: One time just after the enrollment
"Coping Orientations to Problem Experienced- New Italian Version" is a self-report questionnaire that considers different coping modes. The Likert scale ranges from 1 to 4, where 1 stands for "I usually don't do it" and 4 stands for "I almost always do it." The instrument consists of 60 items, divided into 5 independent dimensions: social support, avoidance strategies, positive attitude, problem orientation and transcendent orientation. The scores from 1 to 4 are based on the responses identified by the subject for each item except for 4 "reverse" responses (items 8-20-36-50) for which the chosen score must be reversed. The items are then divided into groups for the identification of the 5 coping factors (social support, avoidance, positive attitude and transcendent orientation). Higher scores indicate greater use of that specific coping strategy.
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 24 Apr 2026.
- BackgroundLazarus, R. S., and Folkman, S. (1984). Stress, Appraisal and Coping. New York, NY: Springer.
- BackgroundSica, C., Magni, C., Ghisi, M., Altoè, G., Sighinolfi, C., Chiri, L. R., & Franceschini, S. (2008). Coping Orientation to Problems Experienced-Nuova Versione Italiana (COPE-NVI): uno strumento per la misura degli stili di coping. Psicoterapia cognitiva e comportamentale, 14(1), 27.
- Background: PubMed 29056838Monti JD, Winning A, Watson KH, Williams EK, Gerhardt CA, Compas BE, Vannatta K. Maternal and Paternal Influences on Children's Coping with Cancer-Related Stress. J Child Fam Stud. 2017 Jul;26(7):2016-2025. doi: 10.1007/s10826-017-0711-y. Epub 2017 Apr 17.
Related trials for Pediatric Cancer
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Not yet recruitingPhase 2
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
Pediatric Chalazia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Coping Behavior, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 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 3 sites 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 Marco Zecca, MD (+390382501258, m.zecca@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child-Parent Relationship Scale (time frame: One time just after the enrollment). The study lists 2 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 NCT06858163, 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 24 Apr 2026.