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IRCT20250118064426N1 IRCT 2025-02-20 Iran University of Medical Sciences Effect of the Family-Centered Empowerment Model on Family Caregivers 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 2024-04-24 anticipated 66 Complete https://irct.ir/trial/81396 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance. N/A Leukemia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period can begin 6 months after the results are published. To whom: The data will be available to researchers in academic and scientific institutions, and people working in other industries can also apply to receive them. Conditions: Using data for scientific purposes. Where to obtain: To receive data, please contact the study's principal investigator (Fatemeh Rashidi). Email address for correspondence: frashidi.nursing@gmail.com How to obtain: After requesting and conducting the necessary checks, the data is provided to the applicant as soon as possible (usually less than a week). Comments:
public Fatemeh Rashidi
No. 63, Golkar Alley, Student Dormitory, Rastavan Street, Pasdaran Street
Tehran Iran (Islamic Republic of) 1946614864 +98 21 2259 4440 rashidi.fa@iums.ac.ir Iran University of Medical Sciences scientific Fatemeh Rashidi
No. 63, corner of Golkar Alley, Rastavan Street, Pasdaran Street
Tehran Iran (Islamic Republic of) 1946614864 +98 918 143 4827 rashidi.fa@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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). 18 years 60 years Both 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. C81-C96 Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue Other N/A 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. 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. Care burden. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Novak and Guest Caregiver Burden Questionnaire. Quality of life. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Cancer Caregiver Quality of Life Questionnaire (CQOLC). Iran University of Medical Sciences Approved 2024-04-13 Ethics committee of Iran University of Medical Sciences Vice President for Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, Hemmat Highway, next to Milad Tower, Tehran. Tehran Tehran Iran (Islamic Republic of)