Investigating the Effect of Educational Intervention Based on the Family-Centered Empowerment Model on the Burden of Care and Quality of Life of Family Caregivers of Patients with Leukemia
Determining the effect of education based on the family-centered empowerment model on the caregiving burden and quality of life of family caregivers of patients with leukemia
Design
The present study is a quasi-experimental study with pretest-posttest and with a control group and an intervention group. The research units were entered into the study by continuous sampling method and were divided into two intervention and control groups. The required sample size at a confidence level of 95%, a power of 80%, and a precision of 8 was calculated according to previous studies as 33 people in each group, which was estimated to be 31 people in each group after considering sample attrition.
Settings and conduct
The family-centered empowerment model was used. The researcher designed an educational booklet for the intervention group on caring for patients with leukemia. The intervention group sessions were conducted in 7 sessions of 60-90 minutes during the four steps of the model during the caregivers' visits to the hospital and in groups of 7-8 people of the main caregivers, using group discussion and question and answer methods, and with educational aids such as educational booklets and PowerPoint files in the Firouzgar Hospital. The control group received only routine training in the ward.
Participants/Inclusion and exclusion criteria
Care for the patient for at least 4 hours a day and care for the patient's first-degree family member; Unwillingness to participate in the study
Intervention groups
The intervention group's training sessions were conducted through the four steps of the family-centered empowerment model with the participation of the patient's primary caregivers. The control group samples only used the usual training in the ward provided by the clinical nurses.
Main outcome variables
burden of care, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250118064426N1
Registration date:2025-02-20, 1403/12/02
Registration timing:retrospective
Last update:2025-02-20, 1403/12/02
Update count:0
Registration date
2025-02-20, 1403/12/02
Registrant information
Name
Fatemeh Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 143 4827
Email address
rashidi.fa@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-24, 1403/02/05
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
2024-04-26, 1403/02/07
Actual recruitment end date
2024-09-21, 1403/06/31
Trial completion date
2024-09-21, 1403/06/31
Scientific title
Investigating the Effect of Educational Intervention Based on the Family-Centered Empowerment Model on the Burden of Care and Quality of Life of Family Caregivers of Patients with Leukemia
Public title
Effect of the Family-Centered Empowerment Model on Family Caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The caregiver must have the ability to understand and learn the study material.
The caregiver must be between the ages of 18 and 60.
The caregiver is a close family member of the patient (father/mother, sister/brother, spouse/child).
The caregiver must be involved in patient care for at least 4 hours a day.
The caregiver has not participated in other similar training programs.
The caregiver should not have a disabling physical or mental disorder (based on the individual's self-report).
The patient the caregiver is caring for is undergoing chemotherapy or has recently received it (at least within the last 3 months).
The patient the caregiver is caring for is an adult (18-60 years old).
The patient being cared for by the caregiver is not in the inpatient ward (selected from among those referred to the blood clinic).
Exclusion criteria:
Incompletely completed questionnaires
Absence of more than one training session
Having any disabling physical or mental problem during the intervention as determined by the doctor
Unexpected events such as migration or death of caregiver/patient
Reluctant to participate in the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
63
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Vice President for Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, Hemmat Highway, next to Milad Tower, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.IUMS.REC.1403.018
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C81-C96
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
care burden
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Novak and Guest Caregiver Burden Questionnaire
2
Description
quality of life
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Cancer Caregiver Quality of Life Questionnaire (CQOLC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After approving the proposal and receiving the code of ethics with the ID (IR.IUMS.REC.1403.018), the researcher obtained the sampling introduction letter and submitted it to the Firoozgar Educational and Medical Center, and after introducing and explaining the research objectives and research implementation method to the relevant authorities, obtained their consent to conduct sampling. Then, the researcher designed an educational booklet on caring for cancer patients for the intervention group samples based on up-to-date evidence by reviewing reliable texts and references. Before sampling, each research unit was given a full explanation of the research objectives. A written informed consent form was provided if they wished to participate in the study. Sampling continued from April to September 2024.The intervention group sessions were scheduled in a four-step program (perceived threat, improving self-efficacy, improving self-esteem through educational participation, and evaluation) in 7 60-90 minute sessions during hospital visits and were conducted as group sessions of 7-8 people with the participation of the patient's primary caregivers (selected based on entry criteria) in the form of lectures, discussions, and question and answer sessions, using educational aids such as whiteboards, educational booklets, and PowerPoint presentation files in the Firouzgar Hospital training classroom by the researcher. This study used the family-centered empowerment model to achieve the goals. This model results from qualitative grounded theory research that, after going through the stages of forming concepts, developing concepts, identifying the psychosocial process of the problem, and resulting in the central variable (family-centered empowerment), went through the modeling stages to create an applied model. The implementation stages of the model include four steps: Step One (Perceived Threat): To examine the perceived threat, attention was paid to two aspects. The first aspect is perceived severity, which includes content related to managing complications and risks of the disease or disease treatments, focusing on (a) infection control, (b) prevention and treatment of mucositis, (c) control of nausea and vomiting, (d) alopecia, (f) diarrhea, (g) bleeding, (h) anemia, and (c) pain control and relief, and was taught to them using group discussion and educational booklets over 3 60-minute sessions. The second aspect is perceived sensitivity, which empowers the caregiver to answer, "How at risk am I as a caregiver for complications from caregiving?" This empowerment was a set of information and skills that were applied to the caregivers' needs in a 60-90 minute session to reduce and prevent complications and risks from caregiving on the caregivers themselves and included skills for controlling anxiety and depression, relieving fatigue, relieving physical problems of the caregiver, resolving problems and concerns related to the period of disease recurrence, and eliminating feelings of guilt and blame in the caregiver with the help of a clinical psychologist. The content provided in this step is as follows: First session: • Initial assessment and introduction to caregivers• Explanation of the study process, including the number and method of holding educational sessions and the necessity of not missing more than one session• Obtaining a written informed consent form• Providing a demographic information form, the quality of life questionnaire for caregivers of patients with cancer and the burden of care by Novak and Guest. Second session (perceived severity):• Familiarizing caregivers with the concept of cancer and leukemia, including:• Types of leukemia• Causes of leukemia• Symptoms caused by the disease• How to diagnose and treat• Treatment measures and methods• Complications caused by the disease and their management (fatigue and intolerance to activity, anemia, bleeding, impaired mental image, body pain and bone pain)• The role of diet and physical activity in the fight against cancer• Familiarity with warning signs and danger signs and how to access health-treatment centers in case of danger signs. Third session (perceived severity):• What is chemotherapy? And how is it done?• Introduction to chemotherapy side effects and the caregiver's role in controlling and managing them, including:• Identifying signs of infection and how to prevent infection• Strategies for maintaining oral mucosa health and controlling chemotherapy-induced mucositis• Strategies for improving appetite in patients• Strategies for controlling nausea and vomiting• Strategies for maintaining skin tissue health and integrity following radiotherapy and chemotherapy• Measures for chemotherapy-induced alopecia and changing mental image• Changes in bowel habits (diarrhea/constipation) due to chemotherapy and how to manage them• Management of fatigue and activity intolerance• Prevention and control of bleeding due to decreased blood cells following chemotherapy• Pharmacological and non-pharmacological strategies for pain control. Session Four (Perceived Sensitivity):• Review and management of side effects of caregiving on caregivers and how to manage them, including:• Skills for controlling anxiety and depression in caregivers• Relieving emotional fatigue in caregivers• Resolving physical problems in caregivers• Resolving feelings of guilt and blame in caregivers• Resolving problems and concerns related to the relapse period. Step Two (Improving self-efficacy): In the fifth session, caregivers were asked to share their experiences and information about the treatment process, assessment, and control of chemotherapy side effects for 60-90 minutes. Other topics discussed in this session are ways to prevent infection, control and relieve pain, improve self-control, experience applying the items taught in the educational sessions in dealing with the patient and their problems, and support other family members. Step Three (Increasing Self-Esteem Through Educational Participation): In this stage (session six), in a 60-90 minute session, after reviewing the topics discussed in the previous sessions, caregivers were asked to participate in educating their patients in the field of recognizing and managing issues related to leukemia and the complications resulting from its treatment, and to encourage them to help themselves; in such a way that they transfer the topics discussed in each group discussion session to their patients and get feedback from them; Then, the caregivers were asked to write down the questions they had in this regard on a sheet of paper and submit them to the researcher; in this way, all the caregivers' notes were received and reviewed, and by doing so, the researcher could understand how successful the caregivers were in transferring educational materials to the patients, and the points that the caregivers had not transferred to the patients were discussed, and if the patients had any questions, they were answered. Step Four, Evaluation: The final evaluation was conducted one month after the last empowerment session for the experimental and control groups. After one month of implementing the program, during a return visit to the hospital or, if there was no return visit, online (by online questionnaire), the questionnaires were again provided to the experimental group and completed.
Category
Other
2
Description
Control group: The research units in control groups just used the usual ward training. This training included educational pamphlets available to all patients and caregivers, educational posters posted on the ward wall with topics related to cancer, and training provided by clinical nurses. After one month of implementing the program, during a return visit to the hospital or, if there was no return visit, online (by online questionnaire), the questionnaires were again provided to the control group and completed. The prepared educational booklet was also made available to the control group samples after receiving the post-test.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences Firoozgar Hospital
Vice chancellor for Research and Technology, Iran University of Medical Sciences
Street address
5th floor of the central headquarters, Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rashidi
Position
Master's degree student in medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 63, Golkar Alley, Student Dormitory, Rastavan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946614864
Phone
+98 21 2259 4440
Email
rashidi.fa@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rashidi
Position
Master's degree student in medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 63, corner of Golkar Alley, Rastavan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946614864
Phone
+98 918 143 4827
Fax
Email
rashidi.fa@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Rashidi
Position
Master's degree student in medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 63, corner of Golkar Alley, Rastavan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946614864
Phone
+98 918 143 4827
Fax
Email
rashidi.fa@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period can begin 6 months after the results are published.
To whom data/document is available
The data will be available to researchers in academic and scientific institutions, and people working in other industries can also apply to receive them.
Under which criteria data/document could be used
Using data for scientific purposes.
From where data/document is obtainable
To receive data, please contact the study's principal investigator (Fatemeh Rashidi).
Email address for correspondence: frashidi.nursing@gmail.com
What processes are involved for a request to access data/document
After requesting and conducting the necessary checks, the data is provided to the applicant as soon as possible (usually less than a week).