Impact of Family-Centered Empowerment on Caregivers of Children with Cancer: a Quasi-Experimental Study Protocol

NCT06810388 | Not Yet Recruiting

• 1 other identifier: YXKY2024460
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to understand the impact of a family empowerment-based intervention program on family caregivers' readiness to care and ability to care. It aims to elucidate whether a health education intervention program based on the Family Empowerment Model improves family caregivers' readiness for care and ability to care. 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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Preparedness for caregiving

  The Caregiver Preparation Scale was used to assess parents' preparedness to care for their children.This scale consists of eight items: preparedness for physical needs, emotional needs, service planning, caregiving stress, comfort care, coping with and managing emergencies, accessing medical information resources and help, and overall caregiving preparedness. A Likert five-point scale was used, with scores ranging from zero to four, indicating "not at all prepared" to "fully prepared," and higher scores reflecting better preparedness for caregiving.

  Completed by the patient's family caregiver, the study participant, within three days of the patient's admission to the hospital, three days after admission to three days prior to discharge, and three days before discharge

• Caring capacity

  The Family Caregiver Task Inventory (FCTI) was used to measure and evaluate family caregivers' caregiving abilities. The FCTI is a self-assessment scale that includes five dimensions: adapting to the role of a caregiver (five items), adapting to and assisting in caregiving (five items), dealing with personal emotions (five items), adjusting to the needs of personal life and caregiving (five items), and evaluating family and social resources (five items). It consists of a total of 25 items. The FCTI uses a three-point Likert scale, with zero indicating "no difficulty," one indicating "some difficulty," and two indicating "great difficulty." Higher scores represent greater difficulty and poorer caregiving capacity.

  Completed by the patient's family caregiver, the study participant, within three days of the patient's admission to the hospital, three days after admission to three days prior to discharge, and three days before discharge

Secondary Outcomes (2)

• Depression Anxiety Stress

  Completed by the patient's family caregiver, the study participant, within three days of the patient's admission to the hospital, three days after admission to three days prior to discharge, and three days before discharge

• Self-efficacy

  Completed by the patient's family caregiver, the study participant, within three days of the patient's admission to the hospital, three days after admission to three days prior to discharge, and three days before discharge

Study Arms (2)

No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter

EXPERIMENTAL

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.

Other: Health education intervention program based on a family-centered empowerment model; Other: Implementation of routine care measures

Routine care group

NO INTERVENTION

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.

Interventions

Health education intervention program based on a family-centered empowerment model OTHER

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.

No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter

Implementation of routine care measures OTHER

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.

No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Xiaowan Li: lead

Related Publications (9)

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10197950 BACKGROUND

• 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.

  PMID: 6662379 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 2270302 BACKGROUND

• Alhani F. Design and evaluation of family-centered empowerment model to prevent iron deficiency anemia. Tehran: Tarbiat Modarres University. Published online; 2003.

  BACKGROUND

• 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.

  PMID: 35964767 BACKGROUND

• 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.

  PMID: 40729689 DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Li

CONTACT

+86 18999394072; yooropo@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nursing

Model Details: The Family-Centred Empowerment Model (FCEM) aims to empower patients and their families by defining essential elements for improving chronic care outcomes. This model builds on the Family-Centred Care philosophy, which emphasises the child's family as the "centre of capacity building"

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: We plan to anonymize and share the data after it is completed in July 2026.