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IRCT20251202068188N1 IRCT 2026-04-22 Bagheiat-allah University of Medical Sciences The effectiveness of a person-centered self-care educational intervention on quality of life and fatigue in women with breast cancer The effectiveness of a person-centered self-care educational intervention delivered through telenursing on quality of life and fatigue in women with breast cancer 2026-05-22 anticipated 76 Complete https://irct.ir/trial/88038 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was purposive, and participants were selected from among patients referring to Imam Reza Hospital according to the inclusion criteria. Subsequently, in order to randomly allocate participants into two groups (intervention and control), block randomization with a block size of four was used. Accordingly, the letter A was assigned to the intervention group and the letter B to the control group. Then, six possible arrangements (AABB, BBAA, ABBA, BAAB, ABAB, BABA) were written on separate sheets of paper and placed into a container. One sheet was randomly selected, and the sequence written on it was recorded and then returned to the container. This procedure was repeated 19 times, and each time the selected sequence was recorded consecutively until the total sample size of 76 was achieved. Numbers from 1 to 76 were assigned to each letter. Each letter was placed in a separate envelope, and the envelopes were labeled with numbers from 1 to 76. Each time a participant was enrolled, the envelopes were opened sequentially, and in this manner it was determined whether the participant was allocated to the intervention or the control group. N/A Breast cancer. Intervention 1: Intervention group: Five weekly sessions of a personalized self-care educational intervention delivered through telenursing. Educational content includes voice-over slides covering self-care strategies tailored to each participant’s needs. Each participant receives a 15–30 minute telephone consultation every two weeks, providing individualized guidance and answers to questions. Total duration of the intervention: 10 weeks (including weekly educational materials and biweekly calls). Intervention 2: Control group: Participants receive standard care provided by the medical center, without additional personalized self-care educational intervention. Yes - There is a plan to make this available What will be shared: All above-mentioned data and documents will be available after study completion in de-identified form. They can be accessed upon written request to the research team, and eligible researchers may use them for scientific research purposes only. When: Access will begin six months after publication of study results and continue for five years thereafter. To whom: Researchers affiliated with academic and research institutions with approved scientific objectives. Conditions: Data may only be used for scientific research purposes and statistical analyses. Commercial use or publication of data without explicit permission from the research team is not allowed. Where to obtain: Applicants should send a written request to the research team via email at: info@baghiatallah.ac.ir How to obtain: 1. Submit a written request to the research team via email 2. Review and approval of the request by the research team 3. Signing a data use agreement by the applicant 4. Provision of de-identified data and documents to the applicant 5. Use of data exclusively for scientific research purposes Comments:
public Foroozan Faghihi
No. 12, Unit 7, Sadati Alley, East Mahboob Majaz, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333638658 +98 31 5328 8305 foroozan.fgh@gmail.com Bagheiat-allah University of Medical Sciences scientific Foroozan Faghihi
No. 12, Unit 7, Sadati Alley, East Mahboob Majaz, Tehran, Iran
Tehran Iran (Islamic Republic of) 1333638658 +98 31 5328 8305 foroozan.fgh@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Women with breast cancer referred to the selected medical center of the armed forces (Emam Reza Hospital) in Tehran in 1404 Ability to work with software applications and mobile devices Patients undergoing chemotherapy, chemotherapy following radiation therapy, or chemotherapy following surgery 18 years 60 years Female Unwillingness to receive the educational program Rapid disease progression or widespread metastasis C50 Malignant neoplasm of breast Lifestyle Lifestyle Intervention group: Five weekly sessions of a personalized self-care educational intervention delivered through telenursing. Educational content includes voice-over slides covering self-care strategies tailored to each participant’s needs. Each participant receives a 15–30 minute telephone consultation every two weeks, providing individualized guidance and answers to questions. Total duration of the intervention: 10 weeks (including weekly educational materials and biweekly calls) Control group: Participants receive standard care provided by the medical center, without additional personalized self-care educational intervention Quality of life score of women with breast cancer based on the breast cancer–specific quality of life questionnaire. Timepoint: Measurement of quality of life at baseline (before the intervention) and at the end of the personalized self-care educational intervention delivered through tele-nursing. Method of measurement: Thirty-item breast cancer quality of life questionnaire assessing functional domains, symptom subscales, and global quality of life. Fatigue score of women with breast cancer in physical, cognitive, and emotional dimensions. Timepoint: Measurement of fatigue at baseline (before the intervention) and at the end of the personalized self-care educational intervention delivered through telenursing. Method of measurement: A fifteen-item cancer-related fatigue questionnaire assessing fatigue in the physical, cognitive, and emotional dimensions. Bagheiat-allah University of Medical Sciences Approved 2025-11-26 Ethics Committee of Baqiyatallah University of Medical Sciences 13th Floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye Iran Street, between Flamk Jonoubi and Zarfshan, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)