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NCT Number: NCT06810388

Impact of Family-Centered Empowerment on Caregivers of Children With Cancer: A Quasi-Experimental Study Protocol

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.

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Key information

Conditions

Malignant Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Preparedness for caregiving

    Time frame: 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

    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.

  2. Caring capacity

    Time frame: 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

    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.

Secondary outcomes

  1. Depression Anxiety Stress

    Time frame: 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

    The 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.

  2. Self-efficacy

    Time frame: 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

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Li

CONTACT

[email protected]

+86 18999394072

Sponsors and collaborators

Lead sponsor

Xiaowan Li

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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