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Active, Not Recruiting

NCT Number: NCT06723496

Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

A) Case groups:

  • 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:

  • 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.
  • the control caregivers:

Inclusion criteria

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

Exclusion criteria

  • Caregivers with history of psychiatric illness.

Treatment and study plan

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

is a checklist parents complete to detect emotional and behavioral problems in children and adolescent, it consists of 113 questions.

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

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

Symptom Checklist -90- Revised (SCL-90-R) for parents

Behavioral

It is a method to evaluate psychological problems and identify symptoms, it includes 90 symptoms and evaluate nine symptomatic dimensions

posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents

Behavioral

It is a 20 -item measure that assess the 20 DSM-5 symptoms of PTSD.

Primary outcomes

  1. Evaluation of psychiatric comorbidity in children with ALL and their caregivers at different stages of illness at South Egypt cancer institute

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • South Egypt Cancer Institute

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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