Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620445
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Efficacy of Psychological Intervention for Children With Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Psychological Intervention for Children With Cancer A Randomized Controlled Trail
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conductued at the Pediatric Oncology Department of the Childrens Hospital PIMS Islamabad over the peroid of six months This single-blinded two-arm RCT study will involve 80 children aged 8 to 16 years with maligancies recieving chemotherapy Participants will be randomly allocated to either interventional or CBT group which will recieve weekly five sessions of Cognitive Behaviour Therapy CBT or the control group which will recieve the usual care CBT session will be contducted by Clinical Psychologist will last 30-35 minutes Outcomes will be measured at Baseine and one month post intervention using Revised Child Anxiety and Depression Scale RCADS and Pediatric Quality of Life Generic Core Score 40
Detailed Description:
Background
Children with cancer and their families experience various psychosocial challenges during and after treatment including physical and cognitive changes due to medical treatment alterations in social and familial roles and the potential threat of death
While most children and families cope and adjust well to the diagnosis and treatment of cancer a subset of children is at increased risk for anxiety depression educational and relationship difficulties Caregivers and siblings of pediatric patients are also at risk for heightened distress and post-traumatic stress Psychosocial care and interventions can play an important role in supporting the well-being of the entire family beginning at diagnosis
The psychological impact of cancer on Pakistani children is diverse and far-reaching ranging from concerns about their future to worries about appearing different from their peers Given the high prevalence of psychological difficulties among pediatric cancer patients in Pakistan it is essential to determine the effectiveness of interventions offered to support their mental health and well-being Studies on cancer patients related to their psychiatric problems are already rare in Pakistan
Objective
The main objective of this study is to compare the effect of psychological intervention such as cognitive-behavioral therapy CBT to the routine care given among pediatric oncology patients The findings of this study will provide evidence to support the integration of psychological intervention strategies into pediatric oncology practice thus adding new knowledge to the literature and helping improve the care of children with malignancies receiving chemotherapy
Study Design
The study will be conducted at the Pediatric Oncology Unit PIMS Islamabad This study will be a two-armed longitudinal randomized control trial expected to run for six months Children with malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups
Intervention
The experimental group will receive five sessions of cognitive-behavioral intervention where maladaptive thoughts and behavior will be identified behavioral activation will be encouraged and deep breathing exercises will be practiced The control group will receive the usual care
Recruitment and Sample
The recruitment process will involve the random selection of children diagnosed with malignancies and undergoing treatment at the Pediatric Oncology Unit the Childrens Hospital PIMS Islamabad Pakistan
Outcome Measures
The outcomes will be measured at baseline post-intervention and one month after the intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 40
Data Analysis
Data analysis will be conducted using SPSS version 23
Ethical Considerations
Permission to conduct the study will be acquired from the Ethical Review Board ERB of PIMS Islamabad
Children with cancer and their families experience various psychosocial challenges during and after treatment including physical and cognitive changes due to medical treatment alterations in social and familial roles and the potential threat of death
While most children and families cope and adjust well to the diagnosis and treatment of cancer a subset of children is at increased risk for anxiety depression educational and relationship difficulties Caregivers and siblings of pediatric patients are also at risk for heightened distress and post-traumatic stress Psychosocial care and interventions can play an important role in supporting the well-being of the entire family beginning at diagnosis
The psychological impact of cancer on Pakistani children is diverse and far-reaching ranging from concerns about their future to worries about appearing different from their peers Given the high prevalence of psychological difficulties among pediatric cancer patients in Pakistan it is essential to determine the effectiveness of interventions offered to support their mental health and well-being Studies on cancer patients related to their psychiatric problems are already rare in Pakistan
Objective
The main objective of this study is to compare the effect of psychological intervention such as cognitive-behavioral therapy CBT to the routine care given among pediatric oncology patients The findings of this study will provide evidence to support the integration of psychological intervention strategies into pediatric oncology practice thus adding new knowledge to the literature and helping improve the care of children with malignancies receiving chemotherapy
Study Design
The study will be conducted at the Pediatric Oncology Unit PIMS Islamabad This study will be a two-armed longitudinal randomized control trial expected to run for six months Children with malignancy receiving chemotherapy will be recruited and randomly assigned to experimental or control groups
Intervention
The experimental group will receive five sessions of cognitive-behavioral intervention where maladaptive thoughts and behavior will be identified behavioral activation will be encouraged and deep breathing exercises will be practiced The control group will receive the usual care
Recruitment and Sample
The recruitment process will involve the random selection of children diagnosed with malignancies and undergoing treatment at the Pediatric Oncology Unit the Childrens Hospital PIMS Islamabad Pakistan
Outcome Measures
The outcomes will be measured at baseline post-intervention and one month after the intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 40
Data Analysis
Data analysis will be conducted using SPSS version 23
Ethical Considerations
Permission to conduct the study will be acquired from the Ethical Review Board ERB of PIMS Islamabad
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None