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IRCT20230616058495N1 IRCT 2023-08-12 Dezfoul University of Medical Sciences The effect of the implementation of the care-nursing protocol (acupuncture, nutrition and psychology) on the side effects of chemotherapy in women with breast cancer and explaining their experiences: a combined study The effect of the implementation of the care-nursing protocol (acupuncture, nutrition and psychology) on the side effects of chemotherapy in women with breast cancer and explaining their experiences: a combined study 2023-11-10 anticipated 110 Complete https://irct.ir/trial/70704 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was conducted as a primary randomized clinical trial in 114 patients with breast cancer. The sample people who were diagnosed with breast cancer at the Imam Hassan Mojtabi Center were selected by purposive sampling and were randomly divided into the experimental group and the control group. The method of randomization is simple random method and the randomization unit is individual. In this study, the participants are randomly placed in separate groups according to the hospital's daily admission list, and the randomization tool is lottery. Random sequence is the use of random allocation. The second step, after creating a random sequence, is to hide the created sequence, and this process is called random assignment hiding, Blinding description: In this study, the statistician will not know about the groups. Therefore, this study will be one-sided blind. N/A Breast cancer patients. Intervention 1: Intervention group: Nutrition intervention In the third group, intervention for people participating in the diet study and recommendations to reduce nausea and improve appetite are considered. The diet is designed in such a way that based on the current weight and taking into account the physical activity factor and the stress factor related to the chemotherapy period, the total daily energy requirement is calculated. Finally, based on the total daily energy requirement, the suitable diet of each person is adjusted. Also, in this study, in order to follow and check the diet of the patients, at the beginning of the study and at the end of the study, the patients will be reminded of their 24-hour food intake for three days about one day off and two days off, through face-to-face or telephone interviews. In order to comply more with the diet, recommendations regarding not changing the framework of the diet plan will be made by phone call every 15 days. Analysis of 24-hour food recall questionnaires will be done using Nutritionist IV (N4) nutritional software. Intervention 2: Control group: Breast cancer patients who do not receive any intervention. Intervention 3: Intervention group: acupuncture In the intervention group (acupuncture receiving group), the acupuncture protocol by a respected physiotherapist (with an acupuncture certificate from the Iranian Physiotherapy Association) will be performed for the patients as follows: acupuncture points that are widely used for nausea, including PC6 (between the palmaris longus and flexor carpi radialis tendons in 2 because it is located proximal to the distal fold of the wrist) and ST36 (on the anterior lateral side of the foot, 1 because it is outside towards the crown) The anterior tibia is (38, 51). Other acupuncture points include Ren 12, LR13, ReN6, ST25 (37), and LI4 point (between the first and second metacarpals) will be used as a general analgesic to reduce pain in this study. All these acupuncture points are manually stimulated every 10 minutes. It should be noted that single-use stainless steel acupuncture needles are used in this research design. Acupuncture treatment of patients for There will be 5 sessions such that the participants will receive acupuncture treatment at the private clinic twice on the day of the start of chemotherapy and once every 4 consecutive days.Each acupuncture session will last approximately 30 minutes. Needles of 0.25 mm diameter and 40 mm length are used for the limb and abdomen area, which are inserted at a depth of 10 to 35 mm and are manually manipulated to create a special sensation called De Qi. Treatment outcomes will include nausea and vomiting and pain, which will be evaluated before the first session and one day after the fifth session and the last day of chemotherapy. It should be noted that during the study period, participants will not undergo other acupuncture treatments or medical interventions. Using a visual pain scale, the level of perceived pain will be measured, which includes a 100 mm long line, the two ends of which indicate no pain and very severe pain, and the patient is asked to mark the average intensity of pain he felt in the past week on the line, and the validity and reliability of this pain assessment method has been evaluated in previous studies. Intervention 4: Intervention group: Psychology In the second intervention group (the group receiving psychological counseling), in the first session of the treatment, the respected clinical psychology expert will explain the treatment steps, chemotherapy side effects, drug effects and possible experienced symptoms to the clients, and then the purpose of the study will be explained and the summary of the intervention will be explained. Misconceptions about the treatment will be discussed and participants will be helped to adjust their understanding of their symptom experience, and then the individual will be given the questionnaires and explained to the individual to complete the questionnaires. And patients receive four 45-minute treatment sessions. Patients will be given a session-by-session treatment manual and an accompanying workbook to make treatment sessions more effective and efficient. The psychological treatment method that will be used to improve the psychological symptoms of breast cancer patients will be a four-session method using coping skills training methods and treatment based on acceptance and commitment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team has not decided on it
public Arezoo Paliziyan
Dezful University of Medical Sciences, Azadegan Square, Mobarez Blvd
Dezfoul Iran (Islamic Republic of) 6461669969 +98 61 4252 8401 arezoo4747@yahoo.com Dezfoul University of Medical Sciences scientific َArezoo Palizian
Dezful University of Medical Sciences, Azadegan Square, Mobarez Blvd
Dezfoul Iran (Islamic Republic of) 6461669969 +98 61 4252 8401 Arezoo4747@yahoo.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Participants must be between 18 and 65 years old. Confirmation of breast cancer diagnosis by pathology and non-metastatic breast cancer. The patient has undergone surgery and then underwent chemotherapy. Informed consent of the patient to accept participation in the study. The consent of the treating oncologist regarding the patient's participation in the present study. The patient does not have an underlying heart disease, does not have a history of previous surgery, and does not have any contraindications for chemotherapy. 18 years 65 years Female Having an underlying heart disease if EF is less than 40. The patient or the treating doctor has requested to withdraw from the study. Have a cognitive disorder. Receive other parallel treatments. The organizers of the plan should diagnose the need to withdraw the patient from the study. C79.2 Secondary malignant neoplasm of skin Lifestyle N/A Lifestyle Lifestyle Intervention group: Nutrition intervention In the third group, intervention for people participating in the diet study and recommendations to reduce nausea and improve appetite are considered. The diet is designed in such a way that based on the current weight and taking into account the physical activity factor and the stress factor related to the chemotherapy period, the total daily energy requirement is calculated. Finally, based on the total daily energy requirement, the suitable diet of each person is adjusted. Also, in this study, in order to follow and check the diet of the patients, at the beginning of the study and at the end of the study, the patients will be reminded of their 24-hour food intake for three days about one day off and two days off, through face-to-face or telephone interviews. In order to comply more with the diet, recommendations regarding not changing the framework of the diet plan will be made by phone call every 15 days. Analysis of 24-hour food recall questionnaires will be done using Nutritionist IV (N4) nutritional software. Control group: Breast cancer patients who do not receive any intervention. Intervention group: acupuncture In the intervention group (acupuncture receiving group), the acupuncture protocol by a respected physiotherapist (with an acupuncture certificate from the Iranian Physiotherapy Association) will be performed for the patients as follows: acupuncture points that are widely used for nausea, including PC6 (between the palmaris longus and flexor carpi radialis tendons in 2 because it is located proximal to the distal fold of the wrist) and ST36 (on the anterior lateral side of the foot, 1 because it is outside towards the crown) The anterior tibia is (38, 51). Other acupuncture points include Ren 12, LR13, ReN6, ST25 (37), and LI4 point (between the first and second metacarpals) will be used as a general analgesic to reduce pain in this study. All these acupuncture points are manually stimulated every 10 minutes. It should be noted that single-use stainless steel acupuncture needles are used in this research design. Acupuncture treatment of patients for There will be 5 sessions such that the participants will receive acupuncture treatment at the private clinic twice on the day of the start of chemotherapy and once every 4 consecutive days.Each acupuncture session will last approximately 30 minutes. Needles of 0.25 mm diameter and 40 mm length are used for the limb and abdomen area, which are inserted at a depth of 10 to 35 mm and are manually manipulated to create a special sensation called De Qi. Treatment outcomes will include nausea and vomiting and pain, which will be evaluated before the first session and one day after the fifth session and the last day of chemotherapy. It should be noted that during the study period, participants will not undergo other acupuncture treatments or medical interventions. Using a visual pain scale, the level of perceived pain will be measured, which includes a 100 mm long line, the two ends of which indicate no pain and very severe pain, and the patient is asked to mark the average intensity of pain he felt in the past week on the line, and the validity and reliability of this pain assessment method has been evaluated in previous studies Intervention group: Psychology In the second intervention group (the group receiving psychological counseling), in the first session of the treatment, the respected clinical psychology expert will explain the treatment steps, chemotherapy side effects, drug effects and possible experienced symptoms to the clients, and then the purpose of the study will be explained and the summary of the intervention will be explained. Misconceptions about the treatment will be discussed and participants will be helped to adjust their understanding of their symptom experience, and then the individual will be given the questionnaires and explained to the individual to complete the questionnaires. And patients receive four 45-minute treatment sessions. Patients will be given a session-by-session treatment manual and an accompanying workbook to make treatment sessions more effective and efficient. The psychological treatment method that will be used to improve the psychological symptoms of breast cancer patients will be a four-session method using coping skills training methods and treatment based on acceptance and commitment. Nausea, vomiting, which score higher in the acute and delayed questionnaire. Timepoint: Before the intervention and after the intervention. Method of measurement: The CINV measurement tool is a standard questionnaire that includes 3 parts: 1. The first part is a predictive nausea and vomiting questionnaire that includes the person's previous experiences of nausea and vomiting before chemotherapy or after chemotherapy. 2. The second part of the tool is related to acute nausea and vomiting, which evaluates the patient's nausea and vomiting during the first 24 hours after chemotherapy and 3. The third part is the questionnaire related to delayed nausea and vomiting, which It examines and evaluates the patient's nausea and vomiting in more than 24 hours since the start of chemotherapy. Assessing pain with the help of a visual pain scale and obtaining a score higher than 6. Timepoint: Before the intervention and after the intervention. Method of measurement: Visual scale is perhaps one of the most well-known methods forto measure mental phenomena in clinical research. This scaleIn the form of a 10 cm line, a score of zero indicates the absence of painAnd a score of ten is the maximum pain that the patient can imaginewhich was graded horizontally in this study. 2 hours afterCaesarean section, the patient was asked to rate the intensity of his pain by putting a markShow on this line. Obtaining a score of 1-3 indicates mild pain.4-7 is moderate pain and 8-10 is severe pain. Validity and reliability of thisThe tool has been validated in several studies. Assessing the appetite status using the Short Appetite Status Questionnaire (SNAQ), a score higher than 14 indicates low appetite. Timepoint: Before the intervention and after the intervention. Method of measurement: Short Appetite Status Questionnaire (SNAQ)Due to the sensitive conditions of the patients, the Short Appetite Questionnaire (SNAQ) of the CNAQ questionnaire will be used to evaluate the appetite. This questionnaire has 4 questions and each question has a score between 1 and 5 points. The final score of this questionnaire is between 4 and 20. Score ≤ 14 indicates low appetite and risk of significant weight loss for the next 6 months. Fatigue score of the individual in the Multidimensional Fatigue Measurement Questionnaire (MFI). Timepoint: Before the intervention and after the intervention. Method of measurement: Also, to evaluate and measure the fatigue of the studied patients, the standard questionnaire of Smets Multidimensional Fatigue Measurement (MFI) will be used. The multidimensional fatigue measurement questionnaire (MFI) was created by Smets (1996), which consists of 20 items and 5 subscales of general fatigue (4 questions), physical fatigue (4 questions), decreased activity (4 questions), and decreased motivation (4 questions). and mental fatigue (4 questions) is formed, which is used to measure fatigue. The MFI measures fatigue as it is felt and expressed by the individual. General fatigue related to a person's general functions during the day, physical fatigue to a physical feeling that is directly related to fatigue, mental fatigue to a decrease in cognitive skills, activity decrease to a decrease in usual and useful daily activities, and decrease in motivation to a decrease or lack. Motivation refers to starting any activity​بررسی جزئیات. Dezfoul University of Medical Sciences Approved 2024-01-09 Ethics Committee of Dezful University of Medical Sciences Dezful University of Medical Sciences, Faculty of Nursing Dezfoul Khouzestan Iran (Islamic Republic of)