]>
IRCT20250611066184N1 IRCT 2025-08-05 Fasa University of Medical Sciences Investigating the effect of family-centered empowerment on the quality of life and self-efficacy in cancer patients undergoing chemotherapy Investigating the effect of family-centered empowerment on the quality of life and self-efficacy in cancer patients undergoing chemotherapy in Shariati Fasa Hospital 2025-10-21 anticipated 80 Complete https://irct.ir/trial/84321 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals who are willing and meet the entry requirements for the study are divided into two groups: intervention and control based on the random selection software. The randomization method of individuals into two groups is carried out using the Balanced Block Randomization method in the Random Allocation software in a one-to-one ratio. 3 in cancer patients undergoing chemotherapy. Intervention 1: Intervention group: Before the intervention, the demographic characteristics checklist, quality of life questionnaire, and self-efficacy questionnaire are completed by the intervention group. And a pre-test is taken from the sample units. For the test group, the family-centered empowerment program is based on the steps of the empowerment model and according to the designed educational program. The first step (perception of threat) sessions will be held in groups of 10 people, consisting of 5 patients and 5 family members (one member of the main family caregiver), in the form of discussion and exchange of opinions and questions and answers by the researcher in one of the hospital meeting rooms using educational aids such as whiteboards, projectors, and PowerPoint. After selecting the first 5 patients, the first step empowerment sessions will be held with a family member of the patient, and the subsequent sessions for the subsequent steps will be held individually (one patient and one family member). The interval between sessions will be between 5 and 7 days, depending on the patient and the family caregiver. The patient will participate in these sessions with the family caregiver. The researcher will have the role of educational, supportive, and guiding participation. The intervention stages are as follows:. The steps of the family-centered empowerment model will be carried out in four main steps: 1- Understanding the threat, 2- Promoting self-efficacy/problem solving, 3- Promoting self-confidence and self-esteem through educational participation, and 4- Evaluation: 1. Step 1, Understanding the threat: The first step in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. In order to sensitize and increase the level of information of patients and their families, group sessions will be held on the nature of the disease, symptoms, complications, prognosis of the disease, diet, treatment regimen, physical activities, and laboratory tests during two sessions (each session 40 to 60 minutes) with educational aids. At the end of the training sessions, questions and answers will be held to ensure understanding of the material. Both the patient and the family caregiver will participate in the discussions and their problems will be identified, discussed and prioritized. 2. The second step, self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40-60 minute sessions) will be held for a group of patients and their families. In these sessions, patients and families will practically face problems and the problem-solving process. In these two sessions, the skills necessary for better disease control will be explained and practiced. Then, patients and families will be asked to practice this skill. For example, one of the problems faced by patients undergoing chemotherapy is nausea and vomiting, and the type of drug that controls this condition and the dosage amount will be demonstrated in class. Also, with regard to the condition of hair loss, how to use a wig will be taught and practiced. 3. Step Three, Self-Belief and Increased Self-Confidence: In this step, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do so with the researcher's help and guidance if needed. The goal of this step is to increase the patients' self-confidence due to observing their ability to provide information to family members and support the family. 4. Step Four, Evaluation: Evaluation consists of 2 steps. 1- Process evaluation 2- Final evaluation 5. Process evaluation will be carried out during the empowerment sessions in such a way that the educational materials of the previous sessions will be evaluated in the form of questions and answers in the next session. The final evaluation will be carried out immediately and two months after the intervention, quality of life and self-efficacy questionnaires will be completed by both intervention groups. And a post-test will be taken again. During this period, the researcher will follow up with the patient and the family caregiver via telephone call. Follow-up and telephone call will be made every 5 days for 5 to 10 minutes to answer their questions. Intervention 2: Control group: Initially, the demographic characteristics checklist, quality of life questionnaire, and efficacy questionnaire are completed by the control group and a pre-test is administered to them. The control group receives training in the form of lectures and face-to-face according to the routine of the inpatient ward. Considering that the training received by patients is during hospitalization and at the time of discharge from the hospital, the quality of life questionnaire and self-efficacy questionnaire are completed again at the time of discharge, and a post-test is also administered. In the following two months, the quality of life and self-efficacy questionnaires are completed and the post-test is administered again. Yes - There is a plan to make this available What will be shared: All potential data is shareable after individuals are de-identified. When: Access begins 4 months after results are published. To whom: Researchers working in academic institutions Conditions: To write meta-analysis studies Where to obtain: Dr. Azam Zare - Fasa University of Medical Sciences How to obtain: Submit a written request Comments:
public Azam Zare
ibn- sina square
Fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 a.zare2002@gmail.com Fasa University of Medical Sciences scientific Azam Zare
ibn-sina square
fasa Iran (Islamic Republic of) ۷۴۶۱۶-۸۶۶۸۸ +98 71 5335 0994 a.zare2002@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) At least two months have passed since the diagnosis of cancer , having a caregiver or active family member not suffering from serious and debilitating complications of cancer undergoing chemotherapy able to speak and communicate able to read and write not suffering from another chronic disease adults aged 30 to 60 years willing to participate in the study , interested and able to learn the material 30 years 60 years Both Absence of more than one session in training sessions unwillingness to continue cooperation in the present study. Z51.11 Encounter for antineoplastic chemotherapy Lifestyle Lifestyle Intervention group: Before the intervention, the demographic characteristics checklist, quality of life questionnaire, and self-efficacy questionnaire are completed by the intervention group. And a pre-test is taken from the sample units. For the test group, the family-centered empowerment program is based on the steps of the empowerment model and according to the designed educational program. The first step (perception of threat) sessions will be held in groups of 10 people, consisting of 5 patients and 5 family members (one member of the main family caregiver), in the form of discussion and exchange of opinions and questions and answers by the researcher in one of the hospital meeting rooms using educational aids such as whiteboards, projectors, and PowerPoint. After selecting the first 5 patients, the first step empowerment sessions will be held with a family member of the patient, and the subsequent sessions for the subsequent steps will be held individually (one patient and one family member). The interval between sessions will be between 5 and 7 days, depending on the patient and the family caregiver. The patient will participate in these sessions with the family caregiver. The researcher will have the role of educational, supportive, and guiding participation. The intervention stages are as follows:. The steps of the family-centered empowerment model will be carried out in four main steps: 1- Understanding the threat, 2- Promoting self-efficacy/problem solving, 3- Promoting self-confidence and self-esteem through educational participation, and 4- Evaluation: 1. Step 1, Understanding the threat: The first step in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. In order to sensitize and increase the level of information of patients and their families, group sessions will be held on the nature of the disease, symptoms, complications, prognosis of the disease, diet, treatment regimen, physical activities, and laboratory tests during two sessions (each session 40 to 60 minutes) with educational aids. At the end of the training sessions, questions and answers will be held to ensure understanding of the material. Both the patient and the family caregiver will participate in the discussions and their problems will be identified, discussed and prioritized. 2. The second step, self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40-60 minute sessions) will be held for a group of patients and their families. In these sessions, patients and families will practically face problems and the problem-solving process. In these two sessions, the skills necessary for better disease control will be explained and practiced. Then, patients and families will be asked to practice this skill. For example, one of the problems faced by patients undergoing chemotherapy is nausea and vomiting, and the type of drug that controls this condition and the dosage amount will be demonstrated in class. Also, with regard to the condition of hair loss, how to use a wig will be taught and practiced. 3. Step Three, Self-Belief and Increased Self-Confidence: In this step, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do so with the researcher's help and guidance if needed. The goal of this step is to increase the patients' self-confidence due to observing their ability to provide information to family members and support the family. 4. Step Four, Evaluation: Evaluation consists of 2 steps. 1- Process evaluation 2- Final evaluation 5. Process evaluation will be carried out during the empowerment sessions in such a way that the educational materials of the previous sessions will be evaluated in the form of questions and answers in the next session. The final evaluation will be carried out immediately and two months after the intervention, quality of life and self-efficacy questionnaires will be completed by both intervention groups. And a post-test will be taken again. During this period, the researcher will follow up with the patient and the family caregiver via telephone call. Follow-up and telephone call will be made every 5 days for 5 to 10 minutes to answer their questions. Control group: Initially, the demographic characteristics checklist, quality of life questionnaire, and efficacy questionnaire are completed by the control group and a pre-test is administered to them. The control group receives training in the form of lectures and face-to-face according to the routine of the inpatient ward. Considering that the training received by patients is during hospitalization and at the time of discharge from the hospital, the quality of life questionnaire and self-efficacy questionnaire are completed again at the time of discharge, and a post-test is also administered. In the following two months, the quality of life and self-efficacy questionnaires are completed and the post-test is administered again. Quality of life. Timepoint: before, after and 2 month after. Method of measurement: To assess quality of life, a specific questionnaire for measuring quality of life in cancer patients, developed by Arneson in 1987, is used. This questionnaire was standardized by Montazeri and colleagues in Iran. Self efficacy. Timepoint: before, after and two month after. Method of measurement: The Self-Care Self-Efficacy Questionnaire was first designed by Lu in 1996 for cancer patients and was translated into a Persian version and used by Azizi. Fasa University of Medical Sciences Approved 2024-10-26 Ethics committee of Fasa University of Medical Sciences Abn Sina Squre Fasa Fars Iran (Islamic Republic of)