Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers

Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers in South Egypt Cancer Institute

Cancer in childhood represents a significant health challenge, with approximately 400,000 children and adolescents aged 0-19 years diagnosed annually. The oncological landscape of pediatric populations is characterized by diverse malignancies, with leukemias, brain cancers, lymphomas, and solid tumors such as neuroblastoma and Wilms tumors constituting the predominant diagnostic categories. Among these, acute lymphoblastic leukemia (ALL) emerges as the most prevalent childhood malignancy.

Historically, a cancer diagnosis portended an almost invariably fatal outcome. However, contemporary medical interventions have dramatically transformed this narrative. Since 1980, mortality rates across pediatric cancer types have declined by more than 50%, representing a remarkable advancement in clinical oncology. Notably, ALL demonstrates an exceptionally optimistic prognosis, with over 90% of patients achieving complete remission.

Despite these encouraging survival statistics, the cancer experience extends beyond physiological parameters. Children diagnosed with leukemia and their familial support systems frequently encounter complex psychological challenges. These manifestations encompass a spectrum of emotional responses, including anxiety, shock, denial, depression, and adaptive difficulties. Critically, these psychological sequelae are not confined to the diagnostic and treatment phases but often persist even after disease remission

The multidimensional nature of the cancer experience prompted the emergence of a specialized subdiscipline in 1992. Termed "psycho-oncology" in the United States and "psychosocial oncology" predominantly in European contexts, this field addresses two fundamental psychological dimensions:

Emotional and psychosocial responses of patients, families, and caregivers throughout the disease trajectory Psychological, behavioral, and social factors potentially influencing cancer morbidity and mortality.

Consequently, contemporary pediatric oncological care adopts a holistic paradigm. The therapeutic objective transcends mere physical restoration, aspiring to ensure the comprehensive social and emotional well-being of both the child and the familial ecosystem.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Lymphoblastic Leukemia ALL
• Intervention / Treatment: Behavioral: Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups.; Behavioral: parent report on child's responses to stress (PCT):is a questionnaire which is used to obtain mothers' and fathers' reports of their children's coping with cancer; Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents; Behavioral: posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine,Assiut university,Assiut,Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The investigators will recruit two groups; first group will be new cases with ALL with their caregivers attending outpatient clinic or admitted inpatient oncological ward and the second group will be healthy control children with their caregivers.

Regarding cases group, every patient will be followed for 6 months with the assessment at diagnosis, post induction phase, post consolidation phase and after 3months from the beginning of the maintenance phase.

Description

A) Case groups:

1. The patients:

Inclusion criteria: the investigators included children with the following criteria:

• Newly diagnosed with ALL
• Aged 6 to 18 years old.

Exclusion criteria: the investigators excluded children with following criteria:

• Children with malignancies other than ALL.

• Age <6 years old and >18 years old.
• Children with chronic illness e.g., diabetes mellitus, inflammatory bowel disease, congenital heart disease, cerebral palsy, etc.

• Children with history of psychiatric illness or intellectual disability.

  2 -the caregivers:

Inclusion criteria:

• The caregivers who are in charge of the case children during treatment.

Exclusion criteria:

• The caregivers with history of psychiatric illness.

B) Control groups:

1. the control children:

   Inclusion criteria:

   • Children with matched age and gender to case group.

   Exclusion criteria:

   • Children with history of having malignancy or current malignancy.
   • Children with history of medical, chronic illness or psychiatric disorders.
2. the control caregivers:

Inclusion criteria:

• Caregivers with matched age and gender to the caregivers' case group.

Exclusion criteria:

• Caregivers with history of psychiatric illness.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy control group	Behavioral: Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups.; is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions.; Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents; It is a method to evaluate psychological problems and identify symptoms, it includes 90 symptoms and evaluate nine symptomatic dimensions
cases group; children with ALL	Behavioral: Child Behavioral Checklist (CBCL):is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions for both groups.; is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions.; Behavioral: parent report on child's responses to stress (PCT):is a questionnaire which is used to obtain mothers' and fathers' reports of their children's coping with cancer; It includes a list of 12 cancer -related stressors (e.g., missing school, frequent hospital or clinic visits, changes in personal appearance), and 57 items reflecting voluntary (coping) and involuntary (automatic) stress responses of children /adolescents in response to cancer-related stressors; Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents; It is a method to evaluate psychological problems and identify symptoms, it includes 90 symptoms and evaluate nine symptomatic dimensions; Behavioral: posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents; It is a 20 -item measure that assess the 20 DSM-5 symptoms of PTSD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of psychiatric comorbidity in children with ALL and their caregivers at different stages of illness at South Egypt cancer institute	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: South Egypt Cancer Institute

Publications and helpful links

General Publications

• Spinetta JJ, Jankovic M, Masera G, Ablin AR, Barr RD, Ben Arush MW, D'Angio GJ, Van Dongen-Melman J, Eden T, Epelman C, Martins AG, Greenberg ML, Kosmidis HV, Oppenheim D, Zeltzer PM. Optimal care for the child with cancer: A summary statement from the SIOP Working Committee on Psychosocial Issues in Pediatric Oncology. Pediatr Blood Cancer. 2009 Jul;52(7):904-7. doi: 10.1002/pbc.21863.
• Holland JC. Psycho-oncology: Overview, obstacles and opportunities. Psychooncology. 2018 May;27(5):1364-1376. doi: 10.1002/pon.4692.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: children; caregivers; Acute Lymphoblastic Leukemia; psychiatry
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: psych-oncology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No