Efficacy of Early Health Intervention Programs on Adverse Effects of Chemotherapy Among Women With Breast Cancer: A Randomized Controlled Trial.

ABSTRACT

Aim Breast cancer is the most frequently diagnosed cancer and the primary cause of cancer-related mortality among women. Advances in medical science have led to chemotherapy drugs that significantly reduce cancer mortality and increase patient's life expectancy. However, the systemic nature of chemotherapy leads to a wide range of physical and psychosocial challenges. Chemotherapy is usually given on an outpatient basis and hence patients have to manage treatment-related symptoms at home. This study aimed to evaluate the efficacy of early health intervention programs, specifically health education and progressive muscle relaxation, in managing the adverse effects of chemotherapy among women with breast cancer. Methods A randomized controlled trial was carried out at the chemotherapy unit of a tertiary care hospital in Thiruvananthapuram, Kerala, India. The research involved 340 female breast cancer patients receiving their initial chemotherapy cycle, divided equally into an experimental group and a control group. Patients in the intervention group received an early health intervention program on the day of their first chemotherapy cycle. These interventions included a 40-minute session comprising health education to manage the adverse effects of chemotherapy at home and a demonstration of progressive muscle relaxation techniques, which must be practiced by the patients two times daily till the end of chemotherapy. Participants in the control group received routine care from the hospital. The primary outcome variable was the adverse effects of chemotherapy. Sociodemographic and clinical information were collected using a structured questionnaire. The severity of adverse effects was assessed using the Common Terminology Criteria for Adverse Events, version 3 (CTCAE v3). Result The average age of participants was 54.7 ± 9.7 years in the control group and 52.4 ± 9 years in the experimental group. The majority in both groups had invasive breast cancer, with 144 (84.7%) in the control group and 153 (90%) in the experimental group. In the post-test, most participants in the control group experienced severe fatigue (136, 80%), mucositis (82, 48.2%), nausea (83, 49.1%), and vomiting (81, 47.6%). Conversely, the majority in the experimental group reported mild mucositis (110, 64.7%), nausea (92, 54.1%), and vomiting (93, 54.7%), along with moderate fatigue (116, 68.2%). Hair loss was incomplete for all participants in the control group and 115 (97.6%) participants in the experimental group. There was a significant difference between the experimental and control groups regarding fatigue (p < 0.001), insomnia (p < 0.01), anorexia (p < 0.01), mucositis (p < 0.01), nausea (p < 0.01), vomiting (p < 0.01), leukopenia (p = 0.001), neutrophil count (p < 0.01), hair loss (p < 0.05), and taste alteration (p < 0.01) during the post-test. Conclusion The study demonstrated that early health interventions, such as health education and progressive muscle relaxation, significantly reduced the adverse effects experienced by breast cancer patients undergoing chemotherapy. This suggests that providing supportive education and exercise training to both patients and caregivers can be beneficial in managing these side effects.