Development and Preliminary Application of a Self-Management Intervention Program for Breast Cancer Patients with Totally Implantable Venous Access Ports (TIVAP) Based on Health Empowerment Theory: A 12-Week Randomized Controlled Trial.

AIM: To develop and evaluate the efficacy of a self-management intervention program based on Health Empowerment Theory for breast cancer patients with totally implantable venous access ports (TIVAP). DESIGN: This study adopted a prospective, parallel-group, randomized controlled trial design. Breast cancer patients with TIVAP were recruited from tertiary hospitals and underwent longitudinal quantitative outcome assessments at four follow-up time points. METHODS: This randomized controlled trial was retrospectively registered with the Chinese Clinical Trial Registry (ChiCTR) on February 2, 2026 (registration number: ChiCTR2600118117). The intervention program was developed through literature review and expert consultation. A total of 54 participants were randomly assigned to the intervention group (n=27) and the control group (n=27). Three patients were lost to follow-up during the 12-week study, and 51 patients (intervention group, n=26; control group, n=25) were included in the final complete-case analysis. The primary outcome was patients' TIVAP self-management ability measured by the C-SUPPH. Secondary outcomes included health empowerment (CEQ), quality of life (EORTC QLQ-BR42), and TIVAP-related complications, which were assessed at baseline (T0), 4 weeks (T1), 8 weeks (T2), and 12 weeks (T3). Repeated-measures ANOVA was used to analyze longitudinal continuous outcomes, and the chi-square test was applied for categorical complication data. For key continuous outcomes, between-group mean differences with 95% confidence intervals were reported to quantify intervention effects and improve result interpretability, rather than relying solely on P-values. All statistical analyses were performed using SPSS 27.0, with P＜0.05 indicating statistical significance. RESULTS: The dropout rate was 5.56%. No significant between-group differences were observed at baseline (P>0.05). From T2 onward, CEQ and C-SUPPH scores were significantly higher in the intervention group than in the control group (P<0.05). Between-group differences in the QLQ-BR42 symptom domain emerged at T2, while differences in the functional domain emerged at T3. At T3, the complication rate was significantly lower in the intervention group (8%, 2/25) than in the control group (30.77%, 8/26; χ²=4.192, P<0.05). CONCLUSION: The intervention effectively reduced TIVAP-related complications and improved health empowerment, self-management efficacy, and quality of life among breast cancer patients, providing a targeted clinical nursing strategy.