Effects of сomprehensive cardio-oncological rehabilitation programs on the psychological status of breast cancer survivors: a pilot randomized study

Background: Psychological abnormalities are common among breast cancer (BC) survivors and may negatively impact their quality of life and outcomes. An improvement in the psychosocial well-being of cancer patients is a key objective of comprehensive cardio-oncology rehabilitation (CORE) programs. Remote CORE models could contribute to increased patient involvement in such programs. Aim: To compare the effectiveness of the off-line (Off-L) and online (On-L) CORE programs regarding their effects on the psychological status parameters in ВС survivors. Methods: This single center pilot randomized prospective study was conducted in a total of 90 BC survivors from 2021 to 2023 in a specialized cardiology clinic. The patients were randomized into three parallel groups in 1:1:1 ratio: the Off-L cardiac rehabilitation program group, the On-L cardiac rehabilitation program group, and the control group. The CORE programs included an educational component addressing cardiovascular risk factors with nutritional counseling, a supervised individualized twice weekly physical exercise program for 3 months (Off-L group), an individualized home-based physical exercise regimen with remote support for 3 months (On-L group), and psychological support with a single session with a psychologist. The control group patients were followed up in their routine clinical practice. In all patients, past history data were collected, including educational level and marital status. Baseline assessments and follow-up evaluation at 6 months included clinical characteristics, stress levels (visual analog scale, VAS), anxiety and depression scores (Hospital Anxiety and Depression Scale, HADS), sleep quality (Pittsburgh Sleep Quality Index), and cognitive function (Montreal Cognitive Assessment, MoCA). Results: The patients median age was 49 years [IQR 46; 56]. At baseline, anxiety symptoms (AS) were found in 45 (50%) patients, depressive symptoms (DS) in 16 (17.8%), high stress levels in 51 (56.7%), sleep disturbances in 80 (89%), and cognitive impairment in 11 (12.4%) patients. There were no differences at baseline between the groups in their main characteristics studied. Over the 6-month follow up, 23 patients dropped from the study. By the end of the observation period, the CORE groups showed a decrease in AS in the Off-L group (n = 20) from 8.5 [6.0; 10.0] to 6.0 [4.0; 9.5] points, with the difference in their median values of -1.5 (95% confidence interval [CI]: -3.0, -0.5, p = 0.026) and in the On-L group from 7.0 [5.0; 8.0] to 5.0 [3.0; 8.0] points (the difference in median values: -2.0, 95% CI: -3.0, 0.5, р = 0.018). No significant changes in AS were found in the control group (the difference in median values: -0.5, 95% CI: -2.0, 0.5, p = 0.181). In the patients with baseline subclinical (8 to 10 points, HADS-A) and clinically significant (≥ 11 points) anxiety, the participation in the CORE programs have led to a higher chance of its decrease either to 8 points or a change in the anxiety category from clinically overt to subclinical (odds ratio 5.667, 95% CI: 1.129, 28.455, р = 0.035). By the end of the follow up, the stress levels in the Off-L group decreased from 8.0 [5.0; 9.0] to 7.0 [4.0; 8.0] VAS points (the difference of the medians: -1.5, 95% CI: -2.0, 0.0, р = 0.050), in the On-L group from 7.0 [6.0; 8.0] to 5.0 [4.0; 6.8] points (the difference of the medians: -1.5, 95% CI: -2.5, -0.5, р = 0.003). There were no significant changes over time in the stress levels in the control group (the difference of the medians: 0.0, 95% CI: -1.0, 1.0, р = 0.974). No statistically significant changes were found in depression scores or sleep quality over the 6-month observation period in the study groups. The On-L group demonstrated a statistically significant improvement in the MoCA cognitive function scores (the difference of the medians: 0.5, 95% CI: 0.0, 1.0, р = 0.021). Conclusion: The participation of BC survivors in the CORE programs facilitates the decrease in anxiety and stress. The On-L CORE program is not inferior to the Off-L program in its impact on the patients’ psychological status. In this regard, further larger studies on the effectiveness of CORE models with various type of telemedicine support seem promising in this patient population.