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IRCT20250901067082N1 IRCT 2025-09-19 Mashhad University of Medical Sciences the Effect of a Supportive-Participator Intervention on the Health-Promoting Behaviors of Breast Cancer Patients Undergoing Chemotherapy the Effect of a Supportive-Participator Intervention on the Health-Promoting Behaviors of Breast Cancer Patients Undergoing Chemotherapy 2025-09-23 anticipated 60 Complete https://irct.ir/trial/85886 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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. N/A Malignant neoplasm of breast. Intervention 1: Intervention group: In the intervention group, patients receive a supportive–participatory intervention delivered by the researcher. This intervention follows a predefined framework and covers key topics related to health-promoting behaviors in breast cancer patients undergoing chemotherapy. Considering the patients’ clinical conditions and the challenges of travel and side effects during chemotherapy, sessions are conducted as 2 face-to-face and 4 virtual meetings. Virtual sessions are held according to patient preference via phone call or their chosen messaging platform (e.g., Eitaa, Rubika, Gap, WhatsApp, etc.).In the first session, in addition to obtaining informed consent and demographic information, patients complete a standardized needs assessment form to identify individual priorities and requirements. While the overall content is fixed, the emphasis and delivery method for each topic are tailored to individual patient needs. If no specific needs are identified, sessions proceed according to the predetermined educational program to cover all essential aspects. This structure allows the researcher to maintain the scientific integrity of the intervention while responding to each patient’s specific needs (Appendix 4).After introducing themselves, establishing rapport, and listening to the patients’ experiences and concerns, the researcher provides explanations about breast cancer and the chemotherapy process, and presents the intervention content—including stress management, physical activity, healthy nutrition, positive interpersonal relationships, spiritual growth, and health responsibility—via pamphlets and written materials. Additionally, the researcher conducts a 15-minute audio phone session for each session to explain the content and answer patient questions. If a patient’s condition is not suitable, the session is conducted over two calls.At the beginning of each session, the researcher listens to the patient’s challenges and attempts to establish a supportive relationship. Through a question-and-answer approach, patients are actively engaged in the learning process. The researcher’s contact information is provided to patients for any questions or further discussions. In each session, patient feedback is collected regarding the topics discussed, and necessary adjustments are made to optimize alignment with educational and clinical needs. In the final face-to-face session, educational content is summarized, and additional feedback is collected from patients.To evaluate the intervention, the Health-Promoting Lifestyle Questionnaire by Walker et al. and the Patient Participation Questionnaire (PPQ) by Berg et al. are used for both groups at three time points: before the intervention (pre-test), after completion of the 6 sessions, and one month post-intervention. Data will ultimately be analyzed using appropriate statistical tests. Intervention 2: Control group: The control group will receive routine chemotherapy care provided by nurses and the treatment team, including general counseling and dietary recommendations delivered face-to-face. To assess the control group, the Health-Promoting Lifestyle Questionnaire by Walker et al. and the Patient Participation Questionnaire (PPQ) by Berg et al. will be administered at three time points for both groups: before the intervention (pre-test), after completion of the 6 sessions, and one month post-intervention. Data will then be analyzed using appropriate statistical tests. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public seyed reza mazloum
East Gate, Ferdowsi University of Mashhad Campus, Dr. Kharazmi Educational Complex, Azadi Square, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3884 6730 nms.pr@mums.ac.ir Mashhad University of Medical Sciences scientific seyed reza mazloum
East Gate, Ferdowsi University of Mashhad Campus, Dr. Kharazmi Educational Complex, Azadi Square, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3884 6730 nms.pr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 20 and 60 years Confirmed diagnosis of breast cancer (grades 1, 2, and 3a based on pathology report) No history of other cancers No experience of other stressful life events in the past 6 months Willingness to participate in the study (informed consent) Ability to communicate verbally and fluency in the Persian language 20 years 60 years Female Unwillingness to continue participation in the study Occurrence of a stressful event during the study for the patient or their family Absence from more than two sessions Receiving other cancer treatments (such as radiotherapy or immunotherapy) Clinical instability of the patient’s condition or patient’s death C50 Malignant neoplasm of breast Lifestyle Lifestyle Intervention group: In the intervention group, patients receive a supportive–participatory intervention delivered by the researcher. This intervention follows a predefined framework and covers key topics related to health-promoting behaviors in breast cancer patients undergoing chemotherapy. Considering the patients’ clinical conditions and the challenges of travel and side effects during chemotherapy, sessions are conducted as 2 face-to-face and 4 virtual meetings. Virtual sessions are held according to patient preference via phone call or their chosen messaging platform (e.g., Eitaa, Rubika, Gap, WhatsApp, etc.).In the first session, in addition to obtaining informed consent and demographic information, patients complete a standardized needs assessment form to identify individual priorities and requirements. While the overall content is fixed, the emphasis and delivery method for each topic are tailored to individual patient needs. If no specific needs are identified, sessions proceed according to the predetermined educational program to cover all essential aspects. This structure allows the researcher to maintain the scientific integrity of the intervention while responding to each patient’s specific needs (Appendix 4).After introducing themselves, establishing rapport, and listening to the patients’ experiences and concerns, the researcher provides explanations about breast cancer and the chemotherapy process, and presents the intervention content—including stress management, physical activity, healthy nutrition, positive interpersonal relationships, spiritual growth, and health responsibility—via pamphlets and written materials. Additionally, the researcher conducts a 15-minute audio phone session for each session to explain the content and answer patient questions. If a patient’s condition is not suitable, the session is conducted over two calls.At the beginning of each session, the researcher listens to the patient’s challenges and attempts to establish a supportive relationship. Through a question-and-answer approach, patients are actively engaged in the learning process. The researcher’s contact information is provided to patients for any questions or further discussions. In each session, patient feedback is collected regarding the topics discussed, and necessary adjustments are made to optimize alignment with educational and clinical needs. In the final face-to-face session, educational content is summarized, and additional feedback is collected from patients.To evaluate the intervention, the Health-Promoting Lifestyle Questionnaire by Walker et al. and the Patient Participation Questionnaire (PPQ) by Berg et al. are used for both groups at three time points: before the intervention (pre-test), after completion of the 6 sessions, and one month post-intervention. Data will ultimately be analyzed using appropriate statistical tests. Control group: The control group will receive routine chemotherapy care provided by nurses and the treatment team, including general counseling and dietary recommendations delivered face-to-face. To assess the control group, the Health-Promoting Lifestyle Questionnaire by Walker et al. and the Patient Participation Questionnaire (PPQ) by Berg et al. will be administered at three time points for both groups: before the intervention (pre-test), after completion of the 6 sessions, and one month post-intervention. Data will then be analyzed using appropriate statistical tests. Health-promoting lifestyle (as assessed by Walker et al.’s questionnaire). Timepoint: Before the intervention (pre-test), after the intervention (completion of 6 sessions), and one month post-intervention. Method of measurement: Walker et al.’s questionnaire. Mashhad University of Medical Sciences Approved 2025-08-26 Research Ethics Committee of School of Nursing & Midwifery - Mashhad University of Medical Sciences East Gate, Ferdowsi University of Mashhad Campus, Dr. Kharazmi Educational Complex, Azadi Square, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)