Impact of Family-Centered Empowerment on Caregivers of Children with Cancer: a Quasi-Experimental Study Protocol
NCT ID: NCT06810388
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
128 participants
INTERVENTIONAL
2025-07-01
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will receive a health education program based on the family empowerment model and will complete questionnaires three days prior to admission, during hospitalization, and three days prior to discharge.This study is a non-pharmacological intervention and will not involve any changes in treatment or chemotherapy regimens.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Family Caregivers in Underserved Populations Providing Complex Cancer Care
NCT05213078
A Study of Family Caregivers' Needs, Burden of Care and Quality of Life Over the Course of a Cancer Illness
NCT03081312
Quality of Life of Older Patients Who Are Undergoing Treatment for Cancer and of Their Family Caregivers
NCT00255697
Investigating the Effects of a Psycho-educational Support Group Therapy on Cancer Caregivers' Burden and Quality of Life
NCT02120183
The Comparative Effectiveness Evaluation of the Impact of Digital Education
NCT06979310
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter
This study will be divided into 2 groups, one group will implement a health education intervention program based on a family-centered empowerment model, and the other group will implement currently available care measures.And the questionnaire was completed for all patients within three days of admission, any day from three days after admission to three days before discharge, and on the day of the three days before discharge.
Health education intervention program based on a family-centered empowerment model
Three sessions of approximately 15-30 min each are conducted within 3 d of the child's admission to the hospital, from the fourth day to the day before discharge, and on the day before discharge. The researcher or charge nurse assesses the caregivers' mastery every week using uniform evaluation criteria and adjusts the topic or number of interventions within each phase based on mastery, with the final intervention content and timeline remaining unchanged.Health education includes: providing family caregivers of children with malignant tumors with knowledge of the disease, guidance on dietary care, instruction on how to recognize symptoms, guidance on medication, post-implantation precautions at the port of infusion, knowledge of blood markers, monitoring of the disease, and emergency treatment.
Implementation of routine care measures
Routine nursing care and current health education content will be provided, including the following: introduction to the department's environment, rules, and regulations; admission counselling; examination guidance; distribution of health education brochures; ongoing education on daily care, medication management, and health practices during hospitalisation; guidance on daily care, medication management, and health education by the nurse in charge; proactive support and communication by medical staff, including resolving questions and sharing caregiver experience; and discharge instructions with follow-up schedules for chemotherapy.
Participants in the control group are offered an FCEM-based intervention regimen on their second admission (at the beginning of the second course of treatment), which is appropriately adapted to the control group's second chemotherapy treatment.
Routine care group
The control group will be offered a health education intervention program based on a family-centered empowerment model at their children next admission for chemotherapy treatment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Health education intervention program based on a family-centered empowerment model
Three sessions of approximately 15-30 min each are conducted within 3 d of the child's admission to the hospital, from the fourth day to the day before discharge, and on the day before discharge. The researcher or charge nurse assesses the caregivers' mastery every week using uniform evaluation criteria and adjusts the topic or number of interventions within each phase based on mastery, with the final intervention content and timeline remaining unchanged.Health education includes: providing family caregivers of children with malignant tumors with knowledge of the disease, guidance on dietary care, instruction on how to recognize symptoms, guidance on medication, post-implantation precautions at the port of infusion, knowledge of blood markers, monitoring of the disease, and emergency treatment.
Implementation of routine care measures
Routine nursing care and current health education content will be provided, including the following: introduction to the department's environment, rules, and regulations; admission counselling; examination guidance; distribution of health education brochures; ongoing education on daily care, medication management, and health practices during hospitalisation; guidance on daily care, medication management, and health education by the nurse in charge; proactive support and communication by medical staff, including resolving questions and sharing caregiver experience; and discharge instructions with follow-up schedules for chemotherapy.
Participants in the control group are offered an FCEM-based intervention regimen on their second admission (at the beginning of the second course of treatment), which is appropriately adapted to the control group's second chemotherapy treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Primary caregiver inclusion criteria: the caregiver is enrolled along with the child, (1) was ≥18 years of age; (2) was a member of the child's immediate family; (3) had cared for the child for the longest period among multiple caregivers; (4) had basic communication and reading skills and was proficient in Chinese; and (5) had no previous or current history of psychiatric illness or consciousness-related disorders.
Exclusion Criteria: (1)Children who abandon treatment or are transferred to a hospital while the study is in progress.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiaowan Li
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaowan Li
Nursing
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Schwarzer R, Bäßler J, Kwiatek P, et al. The assessment of optimistic self-beliefs: Comparison of the German, Spanish, and Chinese Versions of the General Self-efficacy Scale. Appl Psychol. 1997;46:69-88.
Chan CW, Chang AM. Managing caregiver tasks among family caregivers of cancer patients in Hong Kong. J Adv Nurs. 1999 Feb;29(2):484-9. doi: 10.1046/j.1365-2648.1999.00911.x.
Clark NM, Rakowski W. Family caregivers of older adults: improving helping skills. Gerontologist. 1983 Dec;23(6):637-42. doi: 10.1093/geront/23.6.637. No abstract available.
Liu Y, Wang M, Dong X. Reliability and validity of Chinese Version of the Caregiver Preparedness Scale in caregivers of stroke survivors. Chin J Prac Nuts. 2016;32:1045-8.
Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990 Dec;13(6):375-84. doi: 10.1002/nur.4770130605.
Alhani F. Design and evaluation of family-centered empowerment model to prevent iron deficiency anemia. Tehran: Tarbiat Modarres University. Published online; 2003.
Alhani F, Asghari-Jafarabadi M, Norouzadeh R, Rahimi-Bashar F, Vahedian-Azimi A, Jamialahmadi T, Sahebkar A. The effect of family-centered empowerment model on the quality of life of adults with chronic diseases: An updated systematic review and meta-analysis. J Affect Disord. 2022 Nov 1;316:140-147. doi: 10.1016/j.jad.2022.07.066. Epub 2022 Aug 11.
Li X, Yang Y, Chen Q, Ma J, Lu F, Luo X. Effect of a Family-Centered Empowerment Model-Based Intervention on the Caregiving Capacity and Preparedness of Caregivers of Children With Malignant Neoplasms: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2025 Jul 29;14:e73304. doi: 10.2196/73304.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YXKY2024460
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.