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IRCT20170731035424N4 IRCT 2023-08-15 Esfahan University of Medical Sciences Effect of Supportive-Educational Intervention on Caregiving Burden and Quality of Life of Family Caregivers of Gastric Cancer Patients Under Home-Based Palliative Care The Effect of Supportive-Educational Intervention on Caregiving Burden and Quality of Life of Family Caregivers of Gastric Cancer Patients Under Home-Based Palliative Care 2023-08-23 anticipated 64 Complete https://irct.ir/trial/72036 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples will be placed in two groups of 32 people, test and control, after being selected by random block method in the form of blocks of four (2 test persons and 2 control persons) and 16 blocks which are selected by chance. Also, randomization will be done using Random Allocation software version 1. N/A Condition 1: Gastric cancer. Condition 2: Home-based palliative care. Intervention 1: Intervention group: The intervention for the test group will be based on the CARES theoretical framework to address the needs of family caregivers in palliative care settings. This intervention, which includes an educational-supportive program during 4 sessions for four weeks (one session each week) individually and at the patient's home by the researcher and with the presence of a supervisor and also under the supervision of the palliative care team (including: the researcher, supervisor, doctor, psychologist, clergy, nurse, nutritionist) will be done for the caregiver. The first session of the intervention will begin with the introduction of the caregiver and the goals of the research and its process. In this way, the caregivers of the test group were invited by the researcher through a phone call in groups of 8-9 people to the study room of Seyed-al-Shohada Hospital, and each group will get to know the research team and how to participate in the research process during a 90-minute session. In addition, explanations about the concepts of palliative care at home and the caring role will be presented to them, and each of the caregivers will discuss the problems and challenges in the field of patient care. Also, during this meeting, the needs of the caregivers in the field of patient care will be identified, and at the end of the session, the questions and doubts of the caregivers will be answered, and they will be welcomed. The second session of the intervention will be conducted in order to identify the individual needs of the caregiver and develop a training-support program. In this way, after making the necessary arrangements, the researcher, by attending the patient's home together with the supervisor and taking into account the conditions of the home and the caregiver's literacy level, during a 60-minute session, talked with him about his relationship with the patient, the situation Life, occupation, physical-mental health, capacity and willingness to provide care and the impact of care in his/her daily life will be addressed and thus will identify the individual needs of the caregiver. Also, in this active participation, the researcher will answer the questions and doubts of the caregivers. After this meeting, the researcher, in a joint meeting with the presence of the palliative care team and the supervision of the supervisor in the study room of Seyed-al-Shohada Hospital, summarized the needs of the caregivers based on their active participation and benefiting from the results of the qualitative study by Taleghani et al. family caregivers of patients with stomach cancer will pay and finally they will develop an educational-support program. It should be noted that in the second session, there will be an active and two-way telephone follow-up between the researcher and the caregiver with the aim of re-examining the needs of the caregiver, which may not have been addressed during the researcher's presence at the patient's home, in order to respond to these needs if necessary. also be included in the educational-supportive program. In the third session, the training-support program for each caregiver will be implemented individually and his needs will be re-evaluated. In this way, during this meeting, after making the necessary arrangements, the researcher will present the content of the educational-support program for care by being present at the patient's home accompanied by the supervisor. Training on the practical aspects of care (including managing the patient's physical symptoms, acquiring practical skills for daily care of the patient and managing the patient's nutritional plan) as well as focusing on preparing the caregiver for possible confrontation with bereavement and reactions related to it. The main components of this program will be Also, during this 60-minute session, the researcher will review the caregiver's needs, which may not have been addressed in the previous sessions. Since the program will have the ability to be updated, if there are new needs for the caregiver and the educational-support program does not respond to it, the researcher will discuss the matter by phone with the supervisor and consult with him at the same moment. The carer will contact a member of the palliative care team by phone depending on his needs. It should be noted that during this meeting, the active communication between the researcher and the caregiver will be maintained through phone calls in order to resolve possible ambiguities and problems in the implementation of the program. In the fourth session, after making the necessary arrangements, the researcher will again be present at the patient's home accompanied by the supervisor, and while answering questions and doubts regarding the educational-supportive program, he will discuss with the caregiver about the responsiveness of the content provided in order to resolve He will address their needs and problems in patient care and get a general summary of the sessions. At the end of the meeting, the researcher will provide the research questionnaires again to the caregiver to complete. It should be noted that at the same time as this meeting, the research questionnaires will be distributed again by the researcher to the control group to be completed. Intervention 2: Control group: Caregivers in the control group will not receive an intervention like the one intended for the test group during the research period, and they will only receive the routine care provided by the hospital. Yes - There is a plan to make this available What will be shared: By maintaining the confidentiality of the individual characteristics of the participants, the results of the study will be shared based on the objectives of the study. When: The access period will start 1 month after the results are published. To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions are allowed to send requests to receive non-identifiable personal data or other documents. The use of documents and data will be allowed only to reduce the burden of care and improve the quality of life of caregivers of cancer patients, as well as to improve nursing knowledge. Where to obtain: In order to receive the documents, it is necessary to refer to the main executive of the project and the relevant student. Based on this, applicants can send their requests to the responsible executive (Sedighehfarzi@nm.mui.ac.ir) or the student (alihatami@nm.mui.ac.ir) via email. How to obtain: The application is sent via email and the response or sending of documents to the applicant (after the necessary checks to prevent violation of the confidentiality of the participants' information) will be after 2 weeks at most. Comments:
public Ali Hatami
Department of Adult Health Nursing, Nursing and Midwifery School, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 7153 alihatami@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Sedigheh Farzi
Department of Adult Health Nursing, Nursing and Midwifery School, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 7153 Sedighehfarzi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness and written informed consent to participate in the study Being over 18 years old Able to read and write Having a place of residence in the geographical area of Isfahan city The family caregiver should be considered as the main caregiver of the patient who is responsible for all the responsibilities of the patient Caregiver should only take care of a chronic illness in the family Not participating in other research projects in this field 18 years no limit Both Suffering from any mental and physical disorders in such a way as to cause dysfunction Giving the responsibility of caring for the client to another person during the study Incomplete completion of questionnaires Being a member of the health team C16.9 Z51.5 Malignant neoplasm of stomach, unspecified Encounter for palliative care Lifestyle Lifestyle Intervention group: The intervention for the test group will be based on the CARES theoretical framework to address the needs of family caregivers in palliative care settings. This intervention, which includes an educational-supportive program during 4 sessions for four weeks (one session each week) individually and at the patient's home by the researcher and with the presence of a supervisor and also under the supervision of the palliative care team (including: the researcher, supervisor, doctor, psychologist, clergy, nurse, nutritionist) will be done for the caregiver. The first session of the intervention will begin with the introduction of the caregiver and the goals of the research and its process. In this way, the caregivers of the test group were invited by the researcher through a phone call in groups of 8-9 people to the study room of Seyed-al-Shohada Hospital, and each group will get to know the research team and how to participate in the research process during a 90-minute session. In addition, explanations about the concepts of palliative care at home and the caring role will be presented to them, and each of the caregivers will discuss the problems and challenges in the field of patient care. Also, during this meeting, the needs of the caregivers in the field of patient care will be identified, and at the end of the session, the questions and doubts of the caregivers will be answered, and they will be welcomed. The second session of the intervention will be conducted in order to identify the individual needs of the caregiver and develop a training-support program. In this way, after making the necessary arrangements, the researcher, by attending the patient's home together with the supervisor and taking into account the conditions of the home and the caregiver's literacy level, during a 60-minute session, talked with him about his relationship with the patient, the situation Life, occupation, physical-mental health, capacity and willingness to provide care and the impact of care in his/her daily life will be addressed and thus will identify the individual needs of the caregiver. Also, in this active participation, the researcher will answer the questions and doubts of the caregivers. After this meeting, the researcher, in a joint meeting with the presence of the palliative care team and the supervision of the supervisor in the study room of Seyed-al-Shohada Hospital, summarized the needs of the caregivers based on their active participation and benefiting from the results of the qualitative study by Taleghani et al. family caregivers of patients with stomach cancer will pay and finally they will develop an educational-support program. It should be noted that in the second session, there will be an active and two-way telephone follow-up between the researcher and the caregiver with the aim of re-examining the needs of the caregiver, which may not have been addressed during the researcher's presence at the patient's home, in order to respond to these needs if necessary. also be included in the educational-supportive program. In the third session, the training-support program for each caregiver will be implemented individually and his needs will be re-evaluated. In this way, during this meeting, after making the necessary arrangements, the researcher will present the content of the educational-support program for care by being present at the patient's home accompanied by the supervisor. Training on the practical aspects of care (including managing the patient's physical symptoms, acquiring practical skills for daily care of the patient and managing the patient's nutritional plan) as well as focusing on preparing the caregiver for possible confrontation with bereavement and reactions related to it. The main components of this program will be Also, during this 60-minute session, the researcher will review the caregiver's needs, which may not have been addressed in the previous sessions. Since the program will have the ability to be updated, if there are new needs for the caregiver and the educational-support program does not respond to it, the researcher will discuss the matter by phone with the supervisor and consult with him at the same moment. The carer will contact a member of the palliative care team by phone depending on his needs. It should be noted that during this meeting, the active communication between the researcher and the caregiver will be maintained through phone calls in order to resolve possible ambiguities and problems in the implementation of the program. In the fourth session, after making the necessary arrangements, the researcher will again be present at the patient's home accompanied by the supervisor, and while answering questions and doubts regarding the educational-supportive program, he will discuss with the caregiver about the responsiveness of the content provided in order to resolve He will address their needs and problems in patient care and get a general summary of the sessions. At the end of the meeting, the researcher will provide the research questionnaires again to the caregiver to complete. It should be noted that at the same time as this meeting, the research questionnaires will be distributed again by the researcher to the control group to be completed. Control group: Caregivers in the control group will not receive an intervention like the one intended for the test group during the research period, and they will only receive the routine care provided by the hospital. Caregiving burden. Timepoint: Measurement of previous caregiving burden at the beginning of the study (before the start of the intervention), immediately and two months after the intervention. Method of measurement: Zarit caregiving Burden questionnaire. Quality of life. Timepoint: Measurement of previous quality of life at the beginning of the study (before the start of the intervention), immediately and two months after the intervention. Method of measurement: The world health organization quality of life brief version questionnaire. Esfahan University of Medical Sciences Approved 2023-08-05 Research Ethics Committees of Nursing, Rehabilitation and Management schools - Isfahan University of Building No. 4, Vice-Chancellor for Research & Technology, Isfahan University of Medical Sciences, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)