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IRCT20230119057155N2 IRCT 2023-08-27 Esfahan University of Medical Sciences Investigating the effect of blended in-person and on-line supportive care on quality of life of new cases of breast cancer Investigating the effect of blended in-person and on-line supportive care on quality of life of new cases of breast cancer 2023-08-06 anticipated 70 Complete https://irct.ir/trial/70028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this method, the study population will be randomly assigned to three groups, two intervention groups and one control group using the double consent zelen preference method. In order to randomly assign patients to each group, the block balance method will be used in such a way that we use a block of four letters to make random allocation sequences and choose the number of letters in each block as four and choose the total number of blocks that In the end, we will have a list where the mark in front of each number determines which group the person will be assigned to. The mentioned process was done with the help of the Sealedenvelop site, Blinding description: In this study, the study will be blinded. The analyst who must review and analyze the data will be blinded to the type of intervention. N/A Breast cancer. Intervention 1: Intervention group: People who have recently been diagnosed with breast cancer. They are informed that there are a number of support and care services in person. In-person services include two visits to a psychiatrist, psychologist, nutritionist, and spiritual psychologist. Also, cancer-related trainings are provided to them in various fields. Intervention 2: Intervention group: People who have recently been diagnosed with breast cancer. They are informed that there are a number of support and care services available online. These services include an educational site and will be provided to them in the form of a Web-app. They will be provided with cancer-related education in various fields. Intervention 3: Control group: People who have recently been diagnosed with breast cancer. These people are not given any information about these services and support care. Yes - There is a plan to make this available What will be shared: Sharing the information of participants in such a way that they are not identifiable When: 3 months after printing the results To whom: Specialists and researchers Conditions: By obtaining permission from the researcher and informing her/him Where to obtain: By sending an email to Haniyeh Salimi (salimimobina120@gmail.com) How to obtain: By sending an email to Haniyeh Salimi (salimimobina120@gmail.com) Comments:
public Hanieh Salimi Arshad Moghaddam
Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8174673461 0098 32371103 salimimobina120@gmail.com Esfahan University of Medical Sciences scientific Narges Rahmanin
Hezar Jarib street
Isfahan Iran (Islamic Republic of) 8174673461 0098 317928134 nrg-rahmnian@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Women newly diagnosed with breast cancer Oncology specialist referral No serious psychiatric illness No substance abuse or addiction no limit no limit Female metastasis Participating in other treatment programs at the same time. c50 Malignant neoplasm of breast Other Other Other Intervention group: People who have recently been diagnosed with breast cancer. They are informed that there are a number of support and care services in person. In-person services include two visits to a psychiatrist, psychologist, nutritionist, and spiritual psychologist. Also, cancer-related trainings are provided to them in various fields. Intervention group: People who have recently been diagnosed with breast cancer. They are informed that there are a number of support and care services available online. These services include an educational site and will be provided to them in the form of a Web-app. They will be provided with cancer-related education in various fields. Control group: People who have recently been diagnosed with breast cancer. These people are not given any information about these services and support care Hospital anxiety and depression. Timepoint: Before the intervention - after the intervention - 12 weeks after the intervention - 24 weeks after the intervention. Method of measurement: Hospital anxiety and depression scale(HADS). Quality of life of patients. Timepoint: Before the intervention - after the intervention - 12 weeks after the intervention - 24 weeks after the intervention. Method of measurement: EORTC QLQ-C30. Quality of life in breast cancer patients. Timepoint: Before the intervention - after the intervention - 12 weeks after the intervention - 24 weeks after the intervention. Method of measurement: (EORTC QLQ-BR23). Supportive care needs. Timepoint: Before the intervention - after the intervention - 12 weeks after the intervention - 24 weeks after the intervention. Method of measurement: (SCNS). Isfahan university of medical science Approved 2023-02-21 Isfahan University of Medical Sciences - Al-Zahra Research Centers Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)