NCT06858163

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jul 2023Dec 2026

Study Start

First participant enrolled

July 12, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

February 27, 2025

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    One time just after the enrollment

Study Arms (2)

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.

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • ● son/daughter in off-therapy
  • 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 in off-therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedale San Gerardo, SC Ematologia Pediatrica

Monza, Monza-Brianza, 20900, Italy

RECRUITING

SC Ematologia 2 - Oncoematologia pediatrica

Pavia, Pavia, 27100, Italy

RECRUITING

Struttura Complessa di Pediatria e Oncoematologia Pediatrica, Ospedale SS Annunziata

Taranto, Taranto, 74100, Italy

RECRUITING

Related Publications (3)

  • Lazarus, R. S., and Folkman, S. (1984). Stress, Appraisal and Coping. New York, NY: Springer.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29056838BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Oncohematology department

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 5, 2025

Study Start

July 12, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations