Malignant TumorNCT06810388
Impact of Family-Centered Empowerment on Caregivers of Children With Cancer: A Quasi-Experimental Study Protocol
A study testing Health education intervention program based on a family-centered empowerment model and Implementation of routine care measures in people with Malignant Tumor, run by Xiaowan Li.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Health education intervention program based on a family-centered empowerment model and Implementation of routine care measures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Health education intervention program based on a family-centered empowerment model, Implementation of routine care measures
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education intervention program based on a family-centered empowerment modelOther
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 measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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"
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaowan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaowan Li, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810388
- Sponsor's protocol ID
- YXKY2024460
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to anonymize and then share the final data statistics, which will include sociodemographic information such as study participant code, age, and gender, as well as study participant readiness for care scores, ability to care scores, self-efficacy scores, and anxiety-depression scores.
Publications
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.
PubMed 7726811Schwarzer 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.
PubMed 10197950Clark 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.
PubMed 6662379Liu 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.
PubMed 2270302Alhani 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.
PubMed 35964767Li 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.
PubMed 40729689
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06810388
- Acronym / sponsor ID
- YXKY2024460
- Conditions
- Malignant Tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xiaowan LiUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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"
| Arm | Type | Receives |
|---|---|---|
| No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter | Experimental | Other: Health education intervention program based on a family-centered empowerment model, Other: Implementation of routine care measuresThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education intervention program based on a family-centered empowerment modelThree 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. | Other | No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter |
| Implementation of routine care measuresRoutine 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. | Other | No interventions have been assigned to arm 'Intervention group' Intervention 'Health education inter |
Primary outcome
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.
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Results publication: PubMed 7726811Lovibond 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.
- Results publicationSchwarzer 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.
- Results publication: PubMed 10197950Chan 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.
- Results publication: PubMed 6662379Clark 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.
- Results publicationLiu 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.
- Results publication: PubMed 2270302Archbold 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.
- Results publicationAlhani F. Design and evaluation of family-centered empowerment model to prevent iron deficiency anemia. Tehran: Tarbiat Modarres University. Published online; 2003.
- Results publication: PubMed 35964767Alhani 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.
- Derived from this study: PubMed 40729689Li 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.
- Individual participant dataSharing planned: Yes. We plan to anonymize and then share the final data statistics, which will include sociodemographic information such as study participant code, age, and gender, as well as study participant readiness for care scores, ability to care scores, self-efficacy scores, and anxiety-depression scores.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Health education intervention program based on a family-centered empowerment model and Implementation of routine care measures in people with Malignant Tumor, run by Xiaowan Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li (+86 18999394072, yooropo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810388, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.