the Effect of a Supportive-Participator Intervention on the Health-Promoting Behaviors of Breast Cancer Patients Undergoing Chemotherapy

Determining the effect of implementing a supportive–participatory intervention on health-promoting behaviors of breast cancer patients undergoing chemotherapy

A randomized, controlled clinical trial with parallel groups, non-blinded, phase 2–3, including 60 patients. Randomization was performed using block timing via Random Allocation

The study will be conducted in the chemotherapy wards of Omid and Imam Reza hospitals, Mashhad. The intervention group receives a supportive–participatory program covering health-promoting behaviors (2 face-to-face and 4 virtual sessions), while the control group receives routine care. Both groups are assessed using the HPLP and PPQ questionnaires at three time points. The study is non-blinded, and data will be analyzed using appropriate statistical tests.

inclusion criteria: age 20–60 years, confirmed diagnosis of breast cancer (grades 1, 2, 3a), no history of other cancers, no stressful events within the past 6 months, willingness to participate, and ability to communicate in Persian. Exclusion criteria: unwillingness to continue, occurrence of stressful events during the study, absence from more than two sessions, receiving other cancer treatments, and clinical instability or death of the patient.

In the intervention group, patients receive a supportive–participatory intervention from the researcher. This includes training on health-promoting behaviors. Sessions consist of 2 face-to-face and 4 virtual meetings. The content is standardized but adapted to individual patient needs. Consent and a needs assessment are completed at the first session, and a summary with patient feedback is collected at the end. The control group receives no educational intervention and only routine care.

Health-promoting lifestyle

In this study, a block randomization method was applied. Patients were recruited through non-probability convenience sampling, and subsequently assigned to either the intervention or control group using randomized allocation. To ensure proper allocation and reduce selection bias, random sequences were generated using the Random Allocation software with block timing. A randomization sequence was prepared in advance for an 8-week period. The sequence was placed in sealed opaque envelopes to maintain allocation concealment. At the beginning of each week, one envelope was opened, and based on the code inside, all patients recruited during that week were assigned to either the intervention (Group A) or the control group (Group B). This approach minimized the possibility of foreknowledge of group assignment by the allocator, since the assignment sequence was concealed until the time of allocation. No blinding was implemented in this study; however, allocation concealment was maintained to prevent information leakage and ensure methodological rigor.

The decision not to share individual participant data is due to the sensitivity of patient information and the ethical considerations regarding confidentiality and privacy. Sharing the data could potentially risk identifying participants despite anonymization, and therefore, to protect their rights and maintain trust, the data will remain confidential.