Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT07162558
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-Blind (Investigator, Outcomes Assessor):\n\nTo 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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-08-31', 'studyFirstSubmitQcDate': '2025-08-31', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lifestyle Scores', 'timeFrame': 'Lifestyle scores are measured at two time points - baseline (before the intervention) and one month after completion of the empowerment program', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Empowerment Model', 'Quality of Life', 'Pediatric Nursing', 'Children'], 'conditions': ['Leukemia Acute Lymphoid Leukemia (ALL)', 'Lifestyle Intervention for at Least 1 Month']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nParticipants (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.', 'detailedDescription': 'Study Title:\n\nThe Effect of Child-Centered Empowerment on the Lifestyle of Children with Leukemia\n\nStudy Purpose:\n\nThe aim of this study was to investigate the efficacy of a child-centered empowerment model in improving the lifestyle of pediatric patients with leukemia. The intervention was designed to strengthen coping abilities, promote healthier daily habits, and enhance overall well-being, in line with holistic and family-centered nursing principles. The study was conducted as a double-blind randomized clinical trial.\n\nSample Size Determination:\n\nThe statistical population of this study included school-aged children (7-13 years) diagnosed with leukemia and admitted to a pediatric oncology clinic in Tehran. A total of 46 eligible children who met the inclusion criteria were enrolled using purposive sampling. Participants were randomly assigned into experimental (n = 23) and control groups (n = 23).\n\nSample size was determined using the mean comparison formula based on a similar study (Shoghi et al., 2019), with Type I error set at 0.05 and power at 80%. The required sample size was calculated as 19 per group, which was increased to 23 per group to account for an anticipated 20% dropout rate.\n\nTo minimize bias, a double-blind design was used. The researcher responsible for data collection was unaware of group allocations, and the statistician analyzing the data processed them under masked labels (x1 and x2).\n\nTools of Data Collection:\n\nA) Demographic questionnaire: Collected background information including age, gender, weight, height, knowledge of illness, and place of living.\n\nB) Lifestyle questionnaire: A validated 38-item tool assessing five domains-nutrition, sleep, physical activity, physical health, and stress. Each item was rated on a 4-point Likert scale ("often" to "never"), with total scores ranging from 38 to 114, categorized as unfavorable (38-63), average (64-88), and favorable (89-114). Validity and reliability were confirmed in prior studies (Farahani et al., 2018).\n\nC) Pre- and post-intervention lifestyle assessment: Completed by all participants before and one month after the intervention period.\n\nIntervention:\n\nExperimental Group:\n\nChildren and their families participated in a structured child-centered empowerment program consisting of five sessions (30 minutes each) delivered by a trained pediatric nursing expert. The intervention included four dimensions:\n\nPerceived Threat: Increasing awareness of the illness, complications, and treatment process through group discussions.\n\nSelf-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief and self-control.\n\nEducational Participation: Children were provided with educational cards to share learned content with family members, reinforcing knowledge and responsibility.\n\nEvaluation: Ongoing assessment of understanding and active involvement through follow-up questions after each session.\n\nInstructional materials were also shared via social media (WhatsApp) to enhance family engagement.\n\nControl Group:\n\nChildren in the control group received routine care only, with no empowerment training.\n\nImplementation Phase:\n\nThe study was conducted in the pediatric oncology clinic in Tehran. After recruitment, children were randomly allocated into intervention or control groups based on admission order (even-numbered admissions to intervention, odd-numbered to control). All participants completed demographic and lifestyle questionnaires before the intervention, and lifestyle reassessment was conducted one month after program completion.\n\nEthics approval The research received ethical clearance from the Near East University Ethics Review Board with the approval number NUE/2023/117-1776. The initiative closely followed the ethical standards established by the Council of Ethics and was carried out in complete accordance with the principles outlined in the Declaration of Helsinki (1964).\n\nStatistical Analysis:\n\nAll data were analyzed using SPSS version 25. The Kolmogorov-Smirnov test was applied to check data normality. Descriptive statistics (mean, standard deviation, and frequencies) were used for demographic data. Inferential statistics included:\n\nPaired t-test to compare pre- and post-intervention scores within each group Independent t-test to compare differences between experimental and control groups Chi-square test to analyze categorical variables A significance level of P \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged 7-13 years diagnosed with leukemia and admitted to the pediatric oncology clinic.\n\nChildren and parents willing to participate in the study and provide written informed consent (parents) and assent (children).\n\nNo reported history of specific mental disorders as declared by parents.\n\nExclusion Criteria:\n\nInconsistent participation in empowerment sessions (e.g., missing scheduled intervention sessions).\n\nWithdrawal from the study by the child or family at any time. Any condition preventing the child from completing questionnaires or participating in group discussions.'}, 'identificationModule': {'nctId': 'NCT07162558', 'acronym': 'lifestyle', 'briefTitle': 'The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients', 'orgStudyIdInfo': {'id': 'PVF2025CAM004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child-Centered Empowerment', 'description': 'Behavioral: Child-Centered Empowerment Intervention\n\nParticipants 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:\n\nPerceived Threat: Increasing awareness of illness, its complications, and the treatment process through group discussions.\n\nSelf-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief, self-control, and confidence in handling illness-related challenges.\n\nEducational 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.\n\nEvaluation: Continuous follow-up and assessment of learning after each session to ensure understanding and active participation.', 'interventionNames': ['Behavioral: Child-Centered Empowerment Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': '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': [{'name': 'Child-Centered Empowerment Intervention', 'type': 'BEHAVIORAL', 'description': '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:\n\nPerceived Threat: Increasing awareness of illness, its complications, and the treatment process through group discussions.\n\nSelf-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief, self-control, and confidence in handling illness-related challenges.\n\nEducational 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.\n\nEvaluation: Continuous follow-up and assessment of learning after each session to ensure understanding and active participation.', 'armGroupLabels': ['Child-Centered Empowerment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99138', 'city': 'Nicosia', 'state': 'KKTC (Turkish Republic of Northern Cyprus)', 'country': 'Cyprus', 'facility': 'Near East University', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}], 'overallOfficials': [{'name': 'Pouran Varvani Farahani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,', 'investigatorFullName': 'Pouran Varvani Farahani', 'investigatorAffiliation': 'Near East University, Turkey'}}}}