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IRCT20150825023753N20 IRCT 2023-11-14 Shahid Beheshti University of Medical Sciences Investigating the effect of lifestyle education on increasing the level of awareness and performance of cancer patients Investigating the effect of lifestyle education on increasing the level of awareness and performance of cancer patients in reducing complications during chemotherapy 2023-11-16 anticipated 66 Complete https://irct.ir/trial/56059 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By using random allocation software, consecutive permutation blocks with the size of 6 people in each block are made and the patients are divided into two groups A (first treatment method) and B (second treatment method), Blinding description: Due to the clear difference in the treatment method in each study group, blinding is done only at the level of the outcome assessor. The interventionist is different from the outcome assessor. There is no possibility of blinding the patients. N/A Cancer. Intervention 1: Intervention group: In addition to common treatments and recommendations, during an educational session, healthy lifestyle recommendations during chemotherapy along with simple and practical solutions for cancer patients who are candidates for chemotherapy (have not yet started chemotherapy) or have received at most one course of chemotherapy) is explained. The taught materials are also provided to the participants in typed form. The educational content includes explanations about the treatment process (briefly about chemotherapy and its side effects), answers to participants' questions, correcting misconceptions about chemotherapy, and complete explanations about the appropriate lifestyle during chemotherapy. Lifestyle training includes recommendations on food and drinks, the amount of movement and rest, the amount of sleep and wakefulness, the control of constipation, diarrhea, nausea, and vomiting, and the temperament of patients in this course, as well as common medicine recommendations based on the content of the "Nutrition and Cancer" training course provided by WageningenX as well as the results of recent studies. It is presented to the participants through lectures, group discussions, questions and answers, and the exchange of information and experiences. Intervention 2: Control group: They receive common treatments and recommendations and do not participate in the training session. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: One year later To whom: Researchers Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments:
public Dr. Mohammad Mahdi Parvizi
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 mmparvizi@gmail.com Shiraz University of Medical Sciences scientific Dr. Ghazaleh Heydarirad
Shams Alley, Vali-e-Asr Street, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6027 ghazalrad@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having cancer based on the pathology report Candidate for chemotherapy (have not yet started chemotherapy or have completed at least one course of chemotherapy) Willingness to participate in the training class on healthy lifestyle recommendations during the course of chemotherapy 18 years 70 years Both Receive other treatments such as radiotherapy at the same time as chemotherapy. Refuse to receive training Recent participation in similar educational and research meetings C00-C97 Malignant neoplasms Lifestyle Treatment - Other Intervention group: In addition to common treatments and recommendations, during an educational session, healthy lifestyle recommendations during chemotherapy along with simple and practical solutions for cancer patients who are candidates for chemotherapy (have not yet started chemotherapy) or have received at most one course of chemotherapy) is explained. The taught materials are also provided to the participants in typed form. The educational content includes explanations about the treatment process (briefly about chemotherapy and its side effects), answers to participants' questions, correcting misconceptions about chemotherapy, and complete explanations about the appropriate lifestyle during chemotherapy. Lifestyle training includes recommendations on food and drinks, the amount of movement and rest, the amount of sleep and wakefulness, the control of constipation, diarrhea, nausea, and vomiting, and the temperament of patients in this course, as well as common medicine recommendations based on the content of the "Nutrition and Cancer" training course provided by WageningenX as well as the results of recent studies. It is presented to the participants through lectures, group discussions, questions and answers, and the exchange of information and experiences. Control group: They receive common treatments and recommendations and do not participate in the training session. Level of awareness about side effects during chemotherapy. Timepoint: Before and after training. Method of measurement: Life style awareness questionnaire during chemotherapy. Performance level about side effects during chemotherapy. Timepoint: Before training and after three courses of chemotherapy. Method of measurement: Questionnaire of lifestyle performance level during chemotherapy. Patient's quality of life. Timepoint: Before training and after three courses of chemotherapy. Method of measurement: EORTC Quality of Life Questionnaire QLQ-C30. Shahid Beheshti University of Medical Sciences Approved 2023-06-18 Ethics Committee on Biomedical Research of Shahid Beheshti University of Medical sciences Shahid Beheshti University of Medical sciences, Daneshju Blv. Tehran Tehran Iran (Islamic Republic of)