EMOTION: Assessing the Impact of a Telephone Intervention for Patients With Breast Cancer, a Randomized Controlled Trial

PURPOSE Breast cancer diagnosis and treatment cause psychosocial distress that can worsen the disease course and outcomes. We hypothesized that personalized telephone follow-up would reduce stress and anxiety, enhance patients' feeling of safety, and minimize symptom exacerbation. METHODS We conducted a randomized controlled trial to determine the effects of personalized psychological management and support for adverse events (AEs) delivered by two telephone calls during chemotherapy cycles. Calls were conducted by oncology nurses and clinical research associates following a protocol to ensure consistent and supportive communication. We measured changes in Profile of Mood States (POMS) scores between baseline and end of the first chemotherapy (primary outcome), and changes after each chemotherapy cycle of POMS, Hospital Anxiety and Depression Scale, and Core Quality of Life Questionnaire scores. The feasibility, acceptability, and appropriateness of the intervention were also analyzed. RESULTS Two hundred forty-eight women were randomly assigned to the intervention group or control group. We found no significant differences in POMS scores ( P = .23). The intervention's effects varied by educational level, occupation, and treatment, with higher education linked to greater improvement in Vigor, active women showing reduced Depression, and women treated with docetaxel and cyclophosphamide experiencing a larger decrease in Anger. The repeated ANOVA found no significant effect on all scores ( P > .06). The intervention was feasible (89% adherence) and well-received (97.7% satisfaction), but had no effect on AEs. CONCLUSION Personalized telephone intervention was feasible and well-received but did not significantly improve emotional well-being, anxiety, depression, quality of life, and toxicity management compared with standard of care. Subgroup analyses suggest that women with higher education, employment, and specific treatment may benefit, emphasizing the need for tailored approaches.