Protocol for a randomised controlled trial of psychoeducation material for psychological distress and serotonin levels in women with breast cancer post mastectomy in Indonesia

Abstract

AbstractBackground: The prevalence of postmastectomy patients who experience symptoms of anxiety and depression is 40%. The impact of psychological stress due to mastectomy includes loss of self-confidence, specifically, body image, by 63%, lifestyle changes by 51.8%, feeling useless as much as 58% and feeling less cared for by 75%. Patients who experience postmastectomy stress may experience psychological side effects, including a 24% increased chance of cancer recurrence, a 30% increased risk of all-cause mortality, and a 29% greater risk of developing a particular type of breast cancer. The current study will examine whether our recently created nurse-guided psychoeducational material for Indonesian breast cancer survivors who have had mastectomy reduces psychological discomfort.Methods: In Indonesia's Kariadi Hospital Semarang Centre Java, 84 patients will participate in a randomised controlled experiment. Data will be gathered at the start of the intervention (preassessment), 3 to 5 days later (postassessment -1), and 1 to 2 weeks later (follow-up assessment). The primary outcome is the level of psychological distress and serotonin levels. Secondary outcomes are breast cancer post mastectomy score pain level, body image and fatigue.Discussion: If effective, psychoeducation nurse-guided materials will be tested and put into practice in a variety of contexts for city local care that offers health education/psychoeducation to women with breast cancer following mastectomy (such as in the hospital in West Java, Indonesia).Trial registration: TCTR20230501003. Date: Mei 1st,2023.