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IRCT20230730058966N2 IRCT 2024-11-18 Jahrom University of Medical Sciences family and patient-centered empowerment in colorectal cancer Investigating the effect of family and patient-centered empowerment program on quality of life and quality of social communication in patients with colorectal cancer: A clinical trial study 2024-11-21 anticipated 60 Complete https://irct.ir/trial/79889 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, a list of selected samples is prepared and numbered in order. Then, with the help of "Random Number Generator" software, each of the even numbers obtained in each selection will be assigned to the control group and the odd numbers will be assigned to the case group. N/A colorectal cancer patients. Intervention 1: Intervention group: This stage will be carried out in four steps through group discussion sessions for patients and their families. In this stage, based on the results obtained from the questionnaires in the previous session, individuals will be categorized into groups of 5 to 7 people with common needs, and guidance and training related to emphasizing the importance of improving social relationships and methods to improve the quality of life of patients will be provided in four steps over 8 sessions.First Step (Perceived Threat): Includes perceived severity and sensitivity. This step will be conducted in 2 sessions using educational pamphlets and films, and the educational content will include: familiarity with the anatomy and physiology of the intestine and digestive system, acquaintance with colorectal cancer and its treatment methods, symptom management (prevention and reduction of nausea and vomiting, skin and hair damage, fatigue, defecation problems), and mentioning specific examples of their own symptoms. In these sessions, the researcher will have a supportive, guiding, and participatory educational role. The duration of each session will be 40 to 60 minutes, depending on the patients' preference. At the end of each session, there will be a summary and a question-and-answer session, and an educational card containing the session materials will be provided to the patient and the primary caregiver.Second Step (Self-Efficacy Promotion): Four 1-hour sessions will be held using the problem-solving method or group problem-solving. Patients will start the discussion by mentioning their own problems, and their problems will be identified, defined, and prioritized by themselves, then skillful solutions will be taught through scientific demonstration and group discussion. Patients and their families will participate in suggesting and choosing solutions. In these sessions, issues such as self-care in colorectal cancer, family involvement, management of negative emotions and psychological issues (reducing anxiety and depression, stress, and anger), mindfulness, improving sleep patterns, defecation patterns, ways to promote spiritual activity, improving social interactions, increasing positive activities, scheduling a written reminder of medication time, observing health points, and managing fatigue will also be discussed, and muscle relaxation techniques and sports exercises will be demonstrated.Based on the group discussion, the researcher will realize:1- To what extent the educational content has been successfully conveyed 2- Points that have not been conveyed to the patients and active family members will be discussed, and 3- Questions from the active family member and the patient will be answered. In this stage, patients and their families will mentally and practically believe that they can prevent and control the consequences of chemotherapy and its side effects by self-control and adopting preventive behaviors. Patients and active family members will study the pamphlets and ask questions on the subject to the researcher.Third Step (Self-Esteem Enhancement): This step will be conducted using the participatory education method in 1 session. The patient will learn the topics and skills with their active family member. The active family members and the patient will be asked to discuss the topics they will be taught and what they will learn from the educational pamphlets and films under the supervision of the researcher. Then, patients will be asked to practice and repeat the behaviors and skills they have learned to become self-sufficient to the extent that they can perform them without the presence of the researcher. The feeling of learning, the feeling of being able to do so, and receiving encouragement from themselves and the researcher will increase the patient's self-sufficiency and, consequently, their self-esteem. Also, during the self-efficacy and self-esteem intervention, the researcher will evaluate the level of adopting preventive behaviors in each session by asking questions about the correct implementation or elimination of the wrong behavior in relation to the previous session. In these sessions, topics will be expressed by the active family member and the patient, and the researcher will play a facilitating role.Fourth Step (Final Evaluation): The final evaluation will be conducted in 1 session immediately after and one month after the end of the empowerment model. The perceived threat will be evaluated by asking questions about the content of the previous sessions. Self-efficacy will be evaluated by performing the taught skills (such as muscle relaxation techniques, sports movements, etc.). Self-esteem will be evaluated by asking and assessing the level of cooperation and interest of the patient and family in educational participation. Intervention 2: Control group: The control group will receive routine care. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting immediately after publication To whom: all people Conditions: There is no special condition. Any request will be answered by email. There will be no specific restrictions on the use of data or documents. Where to obtain: Request by email to: mahdikarimyar310@gmail.com How to obtain: If the request is received by email, it will be answered as soon as possible. Comments:
public Mahdi Karimyar Jahromi
No.16, Ebrat st, Jahrom
Jahrom Iran (Islamic Republic of) 7419653846 +98 71 5422 1520 mahdikarirmyar310@gmail.com Jahrom University of Medical Sciences scientific Mahdi Karimyar Jahromi
No. 16, Ebrat st, Jahrom
Jahrom Iran (Islamic Republic of) 7419653846 +98 71 5422 1520 mahdikarirmyar310@gmail.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Patient and primary caregiver's willingness and consent to participate in the study Patient and primary caregiver's ability to read and write Patient and primary caregiver must be over 18 years of age The patient and primary caregiver must not have psychiatric disorders (such as depression, psychosis, mania) or mental disorders The primary caregiver should live with the patient The primary caregiver must be an active member of the patient's care The diagnosis of colorectal cancer must be confirmed by an oncologist 18 years no limit Both Absence of the primary caregiver and the patient for more than 2 sessions Death or migration of the patient Lack of cooperation or willingness of the primary caregiver to continue participating in the study Incomplete filling of questionnaires by the patient C19 Malignant neoplasm of rectosigmoid junction Rehabilitation Rehabilitation Intervention group: This stage will be carried out in four steps through group discussion sessions for patients and their families. In this stage, based on the results obtained from the questionnaires in the previous session, individuals will be categorized into groups of 5 to 7 people with common needs, and guidance and training related to emphasizing the importance of improving social relationships and methods to improve the quality of life of patients will be provided in four steps over 8 sessions.First Step (Perceived Threat): Includes perceived severity and sensitivity. This step will be conducted in 2 sessions using educational pamphlets and films, and the educational content will include: familiarity with the anatomy and physiology of the intestine and digestive system, acquaintance with colorectal cancer and its treatment methods, symptom management (prevention and reduction of nausea and vomiting, skin and hair damage, fatigue, defecation problems), and mentioning specific examples of their own symptoms. In these sessions, the researcher will have a supportive, guiding, and participatory educational role. The duration of each session will be 40 to 60 minutes, depending on the patients' preference. At the end of each session, there will be a summary and a question-and-answer session, and an educational card containing the session materials will be provided to the patient and the primary caregiver.Second Step (Self-Efficacy Promotion): Four 1-hour sessions will be held using the problem-solving method or group problem-solving. Patients will start the discussion by mentioning their own problems, and their problems will be identified, defined, and prioritized by themselves, then skillful solutions will be taught through scientific demonstration and group discussion. Patients and their families will participate in suggesting and choosing solutions. In these sessions, issues such as self-care in colorectal cancer, family involvement, management of negative emotions and psychological issues (reducing anxiety and depression, stress, and anger), mindfulness, improving sleep patterns, defecation patterns, ways to promote spiritual activity, improving social interactions, increasing positive activities, scheduling a written reminder of medication time, observing health points, and managing fatigue will also be discussed, and muscle relaxation techniques and sports exercises will be demonstrated.Based on the group discussion, the researcher will realize:1- To what extent the educational content has been successfully conveyed 2- Points that have not been conveyed to the patients and active family members will be discussed, and 3- Questions from the active family member and the patient will be answered. In this stage, patients and their families will mentally and practically believe that they can prevent and control the consequences of chemotherapy and its side effects by self-control and adopting preventive behaviors. Patients and active family members will study the pamphlets and ask questions on the subject to the researcher.Third Step (Self-Esteem Enhancement): This step will be conducted using the participatory education method in 1 session. The patient will learn the topics and skills with their active family member. The active family members and the patient will be asked to discuss the topics they will be taught and what they will learn from the educational pamphlets and films under the supervision of the researcher. Then, patients will be asked to practice and repeat the behaviors and skills they have learned to become self-sufficient to the extent that they can perform them without the presence of the researcher. The feeling of learning, the feeling of being able to do so, and receiving encouragement from themselves and the researcher will increase the patient's self-sufficiency and, consequently, their self-esteem. Also, during the self-efficacy and self-esteem intervention, the researcher will evaluate the level of adopting preventive behaviors in each session by asking questions about the correct implementation or elimination of the wrong behavior in relation to the previous session. In these sessions, topics will be expressed by the active family member and the patient, and the researcher will play a facilitating role.Fourth Step (Final Evaluation): The final evaluation will be conducted in 1 session immediately after and one month after the end of the empowerment model. The perceived threat will be evaluated by asking questions about the content of the previous sessions. Self-efficacy will be evaluated by performing the taught skills (such as muscle relaxation techniques, sports movements, etc.). Self-esteem will be evaluated by asking and assessing the level of cooperation and interest of the patient and family in educational participation. Control group: The control group will receive routine care. Quality of life. Timepoint: before intervention and immediately and 1 month after intervention. Method of measurement: The Quality of Life Questionnaire for Colorectal Cancer Patients (QLQ-CRC). Quality of social communication. Timepoint: before intervention and immediately and 1 month after intervention. Method of measurement: The Social Relationship Quality Scale (SRQS). Jahrom University of Medical Sciences Approved 2024-10-16 Research Ethics Committees of Jahrom University of Medical Sciences Deputy of Research and Technology, Jahrom University of Medical Sciences, Motahari st. Jahrom Fars Iran (Islamic Republic of)