The effectiveness of a person-centered self-care educational intervention delivered through telenursing on quality of life and fatigue in women with breast cancer

Evaluating the effectiveness of a personalized self-care educational intervention delivered through telenursing on quality of life and fatigue in women with breast cancer

Clinical trial, with parallel groups, open-label, randomized, on 76 patients

After allocating patients to the two groups and obtaining informed consent, the study instruments will be provided to the participants. These include three questionnaires: a demographic information questionnaire, the quality of life questionnaire for women with breast cancer, and the cancer-related fatigue assessment questionnaire. To identify patients’ problems and needs, the ORMS (Assessment and Recognition of Needs) questionnaire will also be used. The intervention will consist of five sessions. Educational materials (voice-over slides) will be uploaded weekly in a virtual social media group. Participants in the intervention group will receive a telephone call every two weeks, lasting 15 to 30 minutes. Each participant will receive individualized consultation according to their needs, and their questions will be answered. Then, three months after the start of the intervention, all patients will complete the quality of life and cancer-related fatigue questionnaires again (post-test).

Women with breast cancer referred to the selected medical center of the Armed Forces in Tehran in the year 1404 , with a confirmed diagnosis of stage I-A breast cancer based on biopsy results, undergoing treatment (chemotherapy, chemotherapy following radiotherapy, or chemotherapy following surgery)

Person-centered self-care educational intervention through telenursing

Quality of life score Fatigue score

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.

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.

Access will begin six months after publication of study results and continue for five years thereafter.

Researchers affiliated with academic and research institutions with approved scientific objectives.

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.

Applicants should send a written request to the research team via email at: info@baghiatallah.ac.ir

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