The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients

NCT07162558 | Completed DMC

• 1 other identifier: PVF2025CAM004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aimed to evaluate the effectiveness of a child-centered empowerment model in improving the lifestyle of children with leukemia. The study focused on whether structured empowerment interventions could significantly enhance daily habits and overall well-being in pediatric oncology patients. The main research questions were: Does the child-centered empowerment model improve the lifestyle of children with leukemia? Can this complementary and non-invasive method be considered a viable approach for supporting pediatric care? Participants (N = 46) aged 7-13 years were randomly assigned to either the intervention group, which received empowerment training in four dimensions (perceived threat, self-efficacy, educational participation, and evaluation), or the control group, which received routine care. Pre- and post-intervention assessments were conducted using a validated lifestyle questionnaire measuring nutrition, sleep, physical activity, physical health, and stress.

Conditions

Leukemia Acute Lymphoid Leukemia (ALL); Lifestyle Intervention for at Least 1 Month

Keywords

Empowerment Model; Quality of Life; Pediatric Nursing; Children

Outcome Measures

Primary Outcomes (1)

• Lifestyle Scores

  The primary outcome measure evaluates changes in the lifestyle of children with leukemia. Lifestyle is assessed using a validated lifestyle questionnaire covering five domains: nutrition, sleep, physical activity, physical health, and stress. The tool includes 38 items rated on a 4-point Likert scale ("often" to "never"), with higher scores indicating a more favorable lifestyle.

  Lifestyle scores are measured at two time points - baseline (before the intervention) and one month after completion of the empowerment program

Study Arms (2)

Child-Centered Empowerment

EXPERIMENTAL

Behavioral: Child-Centered Empowerment Intervention Participants in this group receive the child-centered empowerment program, a structured behavioral intervention designed to enhance coping skills, promote self-efficacy, and improve lifestyle in children with leukemia. The program is based on four dimensions of empowerment: Perceived Threat: Increasing awareness of illness, its complications, and the treatment process through group discussions. Self-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief, self-control, and confidence in handling illness-related challenges. Educational Participation: Children receive educational cards at the end of each session and are encouraged to share the learned content with family members to reinforce responsibility and engagement. Evaluation: Continuous follow-up and assessment of learning after each session to ensure understanding and active participation.

Behavioral: Child-Centered Empowerment Intervention

Routine Care

NO INTERVENTION

Participants in this group continue with their usual oncology care and do not receive any additional empowerment training. Routine medical and nursing care is delivered according to standard clinical practice without structured behavioral interventions

Interventions

Child-Centered Empowerment Intervention BEHAVIORAL

Participants in this group receive the child-centered empowerment program, a structured behavioral intervention designed to enhance coping skills, promote self-efficacy, and improve lifestyle in children with leukemia. The program is based on four dimensions of empowerment: Perceived Threat: Increasing awareness of illness, its complications, and the treatment process through group discussions. Self-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief, self-control, and confidence in handling illness-related challenges. Educational Participation: Children receive educational cards at the end of each session and are encouraged to share the learned content with family members to reinforce responsibility and engagement. Evaluation: Continuous follow-up and assessment of learning after each session to ensure understanding and active participation.

Child-Centered Empowerment

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-13 years diagnosed with leukemia and admitted to the pediatric oncology clinic.
• Children and parents willing to participate in the study and provide written informed consent (parents) and assent (children).
• No reported history of specific mental disorders as declared by parents.

You may not qualify if:

• Inconsistent participation in empowerment sessions (e.g., missing scheduled intervention sessions).
• Withdrawal from the study by the child or family at any time. Any condition preventing the child from completing questionnaires or participating in group discussions.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University

Nicosia, KKTC (Turkish Republic of Northern Cyprus), 99138, Cyprus

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pouran Varvani Farahani, PhD

  Study Principal Investigator PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind (Investigator, Outcomes Assessor): To minimize bias, a double-blind approach was employed. The researcher responsible for data collection was unaware of the group assignments, and the statistician analyzing the results was also blinded to the allocation. The data were processed under masked labels (x1 and x2) to preserve objectivity.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,

Model Details: Participants in this clinical trial were randomly assigned to one of two groups: an experimental group receiving the child-centered empowerment intervention and a control group receiving routine pediatric oncology care. Both groups were followed in parallel throughout the study duration.

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 9, 2025
• Study Start: September 2, 2024
• Primary Completion: September 10, 2024
• Study Completion: December 30, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)