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Stepped-Care Support for Children With Leukaemia

NCT07587411 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-18

No results posted yet for this study

Summary

This study aims to develop, culturally adapt, and pilot test a stepped-care psychosocial intervention designed to improve emotional and behavioral health among children with leukemia in Pakistan. Children with leukemia may experience anxiety, depressive symptoms, irritability, sleep disturbance, social withdrawal, treatment-related distress, and behavioral difficulties during the cancer treatment pathway. In resource-constrained settings, structured psychosocial care is often limited or unavailable within routine pediatric oncology services. This study addresses this gap by developing a feasible, culturally responsive, and theory-informed intervention that can be delivered within existing clinical resources.

The study follows a multi-stage intervention-development process guided by the Intervention Mapping framework and Medical Research Council guidance for complex interventions. The stages include: evidence review and expert consultation to identify gaps in current psychosocial care; mixed-methods needs assessment with children, caregivers, and healthcare professionals; refinement of the intervention through focus groups and an e-Delphi process; and pilot testing of the intervention in a two-arm pilot randomized controlled trial.

The pilot trial will include children aged 7 to 14 years with leukemia who are clinically stable and in the remission or maintenance phase of treatment, together with their primary caregivers. Participants will be allocated to either the stepped-care intervention plus routine care or routine care alone. The stepped-care program is delivered over 12 weeks and progresses from low-intensity universal support to more intensive individualized care according to child and family needs. Intervention components include an information booklet, psychoeducational video, face-to-face psychoeducation, peer support, cognitive behavioral strategies, parent-child behavioral training, and one-to-one therapy or referral when indicated. The intervention will be delivered by trained mental health nurses under supervision of a psychologist.

The primary focus of this pilot trial is feasibility and acceptability, including recruitment, retention, attendance, intervention fidelity, completion of outcome measures, and participant satisfaction. Secondary exploratory outcomes include emotional and behavioral functioning, distress, quality of life, depressive symptoms, sleep disturbance, treatment adherence, and family functioning. Findings will guide refinement of the intervention and inform the design of a future fully powered randomized controlled trial.

Conditions

  • Childhood Leukemia

Interventions

BEHAVIORAL

Step Care Intervention

Participants will receive a 12-week stepped-care psychosocial intervention including psychoeducation, peer support, CBT sessions, parent-child training, and individualized therapy along with routine care

Sponsors & Collaborators

  • Zhengzhou University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-03-30
Completion
2026-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07587411 on ClinicalTrials.gov