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IRCT20230402057801N1 IRCT 2023-05-12 Mashhad University of Medical Sciences Evaluating The Effect of Using An Mobile-Application on The Management of Chemotherapy Complication and Quality of Life in Breast Cancer Patients Evaluation of the effect of using mobile application on the management of chemotherapy side effects and quality of life in patients with breast cancer 2023-05-05 anticipated 72 Complete https://irct.ir/trial/69408 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to evaluate the impact of the designed application, patients who have been diagnosed with breast cancer and are receiving chemotherapy in Omid Hospital of Mashhad, who also meet the criteria for entering our study, were randomly divided into two control and intervention groups using the block method. are placed (randomization will be done using the envelope method, the said sequence will be generated using the randomize.com site), Blinding description: In connection with the blinding of the participants, the participants of each group will remain unaware of the existence of the other study group as well as the existence of the application. In connection with the data analyst, after collecting the data, we will give data related to each group to the data analysts without specifying which group they belong to. 2 Breast Cancer. Intervention 1: Intervention group: Receiving chemotherapy in the usual way, along with using the application for 4 weeks at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy. Intervention 2: Control group: Receiving chemotherapy in the usual way, at the same times as before and as it was received in the past, without any intervention from our side and according to the hospital's protocol and past routine at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy. 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 Due to not starting sampling, and collecting the required items, I am still not able to provide a release plan.
public Masoume Sarbaz DinAbadi
Ferdowsi university, Factualy paramedicine
Mashhad Iran (Islamic Republic of) 9351991358 +98 915 519 9599 sarbazm2006@gmail.com Mashhad University of Medical Sciences scientific Marziyeh Raei Mehne
ferdowsi university
mashhad Iran (Islamic Republic of) 9351991358 +98 51 3551 0790 raeem4002@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Literate patients Patients diagnosed with breast cancer Patients undergoing chemotherapy Patients with smartphones that can use this application Ability and willingness to participate in the study 18 years 60 years Female Patients with chronic mental problems and psychiatric diseases, including major depressive disorder and anxiety disorders Presence or history of uncontrolled medical conditions other than cancer Patients participating in another study related to symptom management Patients who undergo radiotherapy and biotherapy at the same time as chemotherapy C50 Malignant neoplasm of breast Lifestyle Lifestyle Intervention group: Receiving chemotherapy in the usual way, along with using the application for 4 weeks at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy. Control group: Receiving chemotherapy in the usual way, at the same times as before and as it was received in the past, without any intervention from our side and according to the hospital's protocol and past routine at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy. Evaluation of complications and quality of life of the participants. Timepoint: At the beginning of the study (before the start of the intervention) and 4 weeks after. Method of measurement: using two standard questionnaires QLQ-BR23 and. Evaluation of the satisfaction of the participants in the intervention group in connection with the use of the application. Timepoint: At the beginning of the study and 4 weeks after using the application. Method of measurement: Using a standard satisfaction questionnaire. Mashhad University of Medical Sciences Approved 2023-03-04 Ethics committee of Mashhad University of Medical Sciences Ferdowsi University Mashhahd Razavi Khorasan Iran (Islamic Republic of)