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Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers

A

Assiut University

Status

Active, not recruiting

Conditions

Acute Lymphoblastic Leukemia ALL

Treatments

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

Funder types

Other

Identifiers

NCT06723496
psych-oncology

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

90 participants in 2 patient groups

cases group
Description:
children with ALL
Treatment:
Behavioral: posttraumatic stress disorders by posttraumatic check list -5 (PCL-5) for parents
Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents
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: 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.
healthy control group
Treatment:
Behavioral: Symptom Checklist -90- Revised (SCL-90-R) for parents
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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