Clinical trial NCT06810388: Impact of Family-Centered Empowerment on Caregivers of Children with Cancer: a Quasi-Experimental Study Protocol
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Tumor
Lead sponsor: West China Second University Hospital
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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"
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preparedness for caregiving
timeFrame: 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
measure: Caring capacity
timeFrame: 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:
measure: Depression Anxiety Stress
timeFrame: 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
measure: Self-efficacy
timeFrame: 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
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Alhani F. Design and evaluation of family-centered empowerment model to prevent iron deficiency anemia. Tehran: Tarbiat Modarres University. Published online; 2003.
citation: 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.