Psychiatric Problems in Children With Acute Lymphoblastic Leukemia and Their Caregivers
NCT ID: NCT06723496
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
90 participants
OBSERVATIONAL
2024-06-01
2025-06-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cases group
children with ALL
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.
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
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
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.
healthy control group
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.
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
Interventions
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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.
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Aged 6 to 18 years old.
* The caregivers who are in charge of the case children during treatment.
• Children with matched age and gender to case group.
• Caregivers with matched age and gender to the caregivers' case group.
Exclusion Criteria
* 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:
• The caregivers with history of psychiatric illness.
B) Control groups:
1. the control children:
* Children with history of having malignancy or current malignancy.
* Children with history of medical, chronic illness or psychiatric disorders.
2. the control caregivers:
• Caregivers with history of psychiatric illness.
6 Years
18 Years
ALL
Yes
Sponsors
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South Egypt Cancer Institute
OTHER
Assiut University
OTHER
Responsible Party
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Gellan Karamalllah Ramadan Ahmed
lecturer of neurology and psychiatry department
Locations
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Faculty of Medicine,Assiut university,Assiut,Egypt
Asyut, , Egypt
Countries
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References
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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.
Other Identifiers
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psych-oncology
Identifier Type: -
Identifier Source: org_study_id