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IRCT20230904059360N1 IRCT 2023-09-23 Esfahan University of Medical Sciences Investigating the effect of the program based on the common-sense model on breast cancer Investigating the effect of the program based on the common-sense model on illness perception and health-promoting behaviors of women with breast cancer 2023-10-02 anticipated 72 Complete https://irct.ir/trial/72677 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study the randomization will be done using block randomization method. In order to allocate the patients randomly into Intervention and control groups, at first 18 blocks of size 4 with C and T letters (The letters indicate the intervention and control groups) are created. Then the blocks are randomly selected and arranged to obtain a sequential combination of 72 letters. Each letter will be placed in a sealed packet according to the obtained sequence. N/A Breast cancer. Intervention 1: Intervention group: In the intervention group, the intervention will be held in the form of four face-to-face sessions for 60 minutes based on the common sense model during four consecutive weeks, with the main content of the sessions being the same for all patients and including six concepts of illness perception (including identity, cause, timeline, consequences , treatment and control).The time of the meetings will be determined in coordination with the research units. Related to the disease control dimension, from the second session, nutrition, physical activity, health responsibility, spiritual growth, interpersonal relationships and stress management are taught to the units of the intervention group with the cooperation of nutrition expert and psychologist. This training will be in the form of showing clips, lectures and discussions, and presenting booklets and pamphlets, and patients will be grouped in groups of four based on the time priority of entering the study. From the fifth to the seventh weeks, in the Eitaa and Bale social media groups, question and answer sessions and discussions will be held on a weekly basis, and in the eighth week, the members of the intervention group will be asked to answer the questionnaires on Brief Illness Perception and Health Promoting Lifestyle Profile-II . Intervention 2: Control group: Participants in the control group received no advice to attend training sessions and received routine care and were only asked to complete questionnaires. After collecting the questions, the people of the control group will be given the booklet of the training sessions of the intervention group, and the first training session will be held for the group that has the same training session as the intervention. 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 only to improve the understanding of the disease and the health-promoting behaviors of cancer patients. 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 ( bahrami@nm.mui.ac.ir) or the student (fatemealidoosti@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 Fatemeh Alidousti
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 fatemealidoosti@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Masoud Bahrami
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 3792 7565 bahrami@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) According to the pathology sheet, the diagnosis of breast cancer has been established for the patient. The patient should be aware of the diagnosis of her disease. The patient must be at least 18 years old. The patient has the ability to speak and communicate verbally. The patient must be able to read and write in Farsi at least to complete the questionnaire. At least two months and a maximum of one year have passed since the active treatment of breast cancer. According to pathology documentation, the disease was diagnosed in stages I to IIIA. 18 years no limit Female According to the medical file documentation, the patient has a history of psychiatric illness requiring hospitalization or drug treatment. There is a family history of breast cancer in the patient's first degree family (mother, sister, father and brother) based on the question of the patient. The patient does not consent to participate in the research. C50.9 Malignant neoplasm of breast of unspecified site Lifestyle Lifestyle Intervention group: In the intervention group, the intervention will be held in the form of four face-to-face sessions for 60 minutes based on the common sense model during four consecutive weeks, with the main content of the sessions being the same for all patients and including six concepts of illness perception (including identity, cause, timeline, consequences , treatment and control).The time of the meetings will be determined in coordination with the research units. Related to the disease control dimension, from the second session, nutrition, physical activity, health responsibility, spiritual growth, interpersonal relationships and stress management are taught to the units of the intervention group with the cooperation of nutrition expert and psychologist. This training will be in the form of showing clips, lectures and discussions, and presenting booklets and pamphlets, and patients will be grouped in groups of four based on the time priority of entering the study. From the fifth to the seventh weeks, in the Eitaa and Bale social media groups, question and answer sessions and discussions will be held on a weekly basis, and in the eighth week, the members of the intervention group will be asked to answer the questionnaires on Brief Illness Perception and Health Promoting Lifestyle Profile-II . Control group: Participants in the control group received no advice to attend training sessions and received routine care and were only asked to complete questionnaires. After collecting the questions, the people of the control group will be given the booklet of the training sessions of the intervention group, and the first training session will be held for the group that has the same training session as the intervention. The score of illness perception in the Brief Illness Perception Questionnaire (Brief IPQ). Timepoint: Illness perception is checked before the start of the study and eight weeks after the start of the study. Method of measurement: Brief Illness Perception Questionnaire (Brief IPQ). The score of health promoting behaviors from the Health Promoting Behaviors Questionnaire (HPLPII). Timepoint: Health-promoting behaviors before the intervention and eight weeks after the start of the intervention are measured through a questionnaire. Method of measurement: Health Promoting Lifestyle Profile-II (HPLP-II) Questionnaire. Esfahan University of Medical Sciences Approved 2023-09-17 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)