Efficacy of Psychological Intervention for Children With Cancer

NCT06620445 | Not Yet Recruiting DMC

• 1 other identifier: F.1-1/2015/ERBSZABMU/1311
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conductued at the Pediatric Oncology Department of the Children's 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 4.0.

Conditions

Clinical Depression; Clinical Anxiety; Quality of Life

Keywords

Psychological Intervention; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• Revised Child Anxiety and Depression Scale (RCADS)

  The RCADS is a standardized, self reported scale measuring anxiety and depression symptoms among children aged 8-18 years.

  Baseline (before the intervention) and one month post intervention (after the five weekly sessions of CBT)

Secondary Outcomes (1)

• Pediatric QoL

  Baseline and one month post intervention

Study Arms (2)

Interventional Group

EXPERIMENTAL

The Intervention or CBT group included 40 children aged 8-16 years with malignancies recieving chemotherapy. They will recieve weekly five sessions of CBT (30-35 minutes per session)

Behavioral: Interventiion or CBT Group

Control or Usual Care Group

NO INTERVENTION

The Control or No Intervention Group also known as Comparision Group or Usual Group will recieve the standard care or usual care for their condition. It will serve as a baseline for the CBT or Intervention Group.

Interventions

Interventiion or CBT Group BEHAVIORAL

This RCT aims to evaluate the effect of Cognitive Behavioral Therapy (CBT) compared to usual care (UC) in pediatric oncology patients. We hypothesize that those receiving CBT will report lower depression and anxiety and improved QoL six months post-enrollment.

Also known as: Cognitive or Pschological Intervention

Interventional Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 16-18 years
• Diagnosed with malignancy
• Recieving chemotherapy at the Pediatric Oncology Department of PIMS Islamabad
• Able to understand and participate in CBT sessions
• Parent/Caregiver consent and child assent
• Exlusion Criteria:
• Children with severe cognitive impairment or intellectual disability
• Children with a comorbid medical conditions
• Children whose parents or caregivers are unable to provide consent

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Muhammad Wasim Khan

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Neoplasms

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants (Children/Guaddians or Parents) are unaware of which group they are assigned (CBT group or usual care group). Researcher are aware of the group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammad Wasim Khan

Model Details: This single-blinded, two-arm randomized controlled trial will involve 80 children aged 8-16 with malignancies receiving chemotherapy. Participants will be randomly assigned to either the experimental group, which will receive five weekly sessions of cognitive-behavioral intervention, or the control group, which will receive usual care. Each intervention session will last 30-35 minutes. Outcomes will be measured at baseline and one-month post-intervention using the Revised Child Anxiety and Depression Scale and Pediatric Quality of Life Inventory Generic Core Score 4.0.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: June 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)