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

Effect of a Family-centred Empowerment Model-based Intervention on the Caregiving Capacity and Preparedness of Caregivers of Children with Malignant Neoplasms: a Protocol for a Quasi-experimental Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06810388
Enrollment
128
Registered
2025-02-05
Start date
2025-07-01
Completion date
2026-07-01
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumor

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.

Interventions

OTHERHealth 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.

OTHERImplementation 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.

Sponsors

Xiaowan Li
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

(1) children aged 0-18 years old, (2) those clinically diagnosed with malignant neoplasms, and (3) first-time visitors to our hospital. 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.

Design outcomes

Primary

MeasureTime frameDescription
Preparedness for caregivingCompleted 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 dischargeThe 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.
Caring capacityCompleted 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 dischargeThe 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.

Secondary

MeasureTime frameDescription
Depression Anxiety StressCompleted 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 dischargeThe Depression Anxiety Stress Scale (DASS-21) evaluates depression, anxiety, and stress levels in family caregivers. It contains 21 items across three dimensions: depression, anxiety, and stress. The depression subscale includes items 3, 5, 10, 13, 16, 17, and 21; the anxiety subscale includes items 2, 4, 7, 9, 15, 19, and 20; and the stress subscale includes items 1, 6, 8, 11, 12, 14, and 18. A Likert four-point scale was used, with scores ranging from zero (did not apply at all) to three (applied most or all of the time). Higher scores indicate higher levels of depression, anxiety, and stress.
Self-efficacyCompleted 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 dischargeThe General Self-Efficacy Scale assesses the self-efficacy of family caregivers. It contains 10 items within one dimension and is scored on a four-point Likert scale, ranging from one (not at all true) to four (exactly true), with a total score of 10 to 40. Higher scores indicate better general self-efficacy.

Contacts

Primary ContactLi
yooropo@outlook.com+86 18999394072

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026