Purpose: An interplay of clinical and psychosocial variables affects breast cancer patients’ experiences and clinical trajectories. Several studies investigated the role of socio-demographic, clinical, and psychosocial factors in predicting relevant outcomes in breast cancer care, thus developing predictive models. Our aim is to summarize predictive models for specific psychological and behavioral outcomes: psychological distress, quality of life, and medication adherence. Specifically, we aim to map the determinants of the outcomes of interest, offering a thorough overview of these models. Methods: Databases (PubMed, Scopus, Embase) have been searched to identify studies meeting the inclusion criteria: a breast cancer patients’ sample, development/validation of a predictive model for selected psychological/behavioral outcomes (ie, psychological distress, quality of life, and medication adherence), and availability of English full-text. Results: Twenty-one papers describing predictive models for psychological distress, quality of life, and adherence to medication in breast cancer were included. The models were developed using different statistical approaches. It has been shown that treatment-related factors (eg, side-effects, type of surgery or treatment received), socio-demographic (eg, younger age, lower income, and inactive occupational status), clinical (eg, advanced stage of disease, comorbidities, physical symptoms such as fatigue, insomnia, and pain) and psychological variables (eg, anxiety, depression, body image dissatisfaction) might predict poorer outcomes. Conclusion: Predictive models of distress, quality of life, and adherence, although heterogeneous, showed good predictive values, as indicated by the reported performance measures and metrics. Many of the predictors are easily available in patients’ health records, whereas others (eg, coping strategies, perceived social support, illness perceptions) might be introduced in routine assessment practices. The possibility to assess such factors is a relevant resource for clinicians and researchers involved in developing and implementing psychological interventions for breast cancer patients.

Heart Rate Variability (HRV) Biofeedback (BFB) has been shown to improve autonomic balance and wellbeing in chronic diseases. As cardiac variability represents an index of cognitive and emotional regulation, HRV-BFB has been shown to lead to improvements in physiological and psychological adaptability and quality of life. However, knowledge of HRV-BFB in cancer patients is lacking, and available results are diversified according to methods and outcomes. The present paper undertakes a scoping review, exploring the use of HRV-BFB to modulate autonomic balance, cancer symptom management, and quality of life in cancer. This scoping review analyzes empirical evidence considering study designs, BFB methods, and psychophysiological outcomes. Research that focused on HRV-BFB effects in cancer patients was selected (79%). In addition, a systematic review and meta-analysis (31%) focusing on HRV, or BFB in chronic conditions, including cancer, were considered. The studies examined BFB treatment for thyroid, lung, brain or colon cancer, hematologic cancer, and survivors or terminal cancer patients. Retrieved studies reported physiological and psychological indices as primary outcomes: they included HRV values, sleep, pain, fatigue, depression, anxiety, and quality of life. Although the heterogeneity of publications makes it difficult to generalize the effectiveness of HRV-BFB, the training has been proven to improve cancer symptoms and well-being.

Background: Adherence to oral anticancer treatments is critical in the disease trajectory of patients with breast cancer. Given the impact of nonadherence on clinical outcomes and the associated economic burden for the health care system, finding ways to increase treatment adherence is particularly relevant. Objective: The primary end point is to evaluate the effectiveness of a decision support system (DSS) and a machine learning web application in promoting adherence to oral anticancer treatments among patients with metastatic breast cancer. The secondary end point is to collect a set of new physical, psychological, social, behavioral, and quality of life predictive variables that could be used to refine the preliminary version of the machine learning model to predict patients’ adherence behavior. Methods: This prospective, randomized controlled study is nested in a large-scale international project named “Enhancing therapy adherence among metastatic breast cancer patients” (Pfizer 65080791), aimed to develop a predictive model of nonadherence and associated DSS and guidelines to foster patients’ engagement and therapy adherence. A web-based DSS named TREAT (treatment adherence support) was developed using a patient-driven approach, with 4 sections, that is, Section A: Metastatic Breast Cancer; Section B: Adherence to Cancer Therapies; Section C: Promoting Adherence; and Section D: My Adherence Diary. Moreover, a machine learning–based web application was developed to predict patients' risk factors of adherence to anticancer treatment, specifically pertaining to physical status and comorbid conditions, as well as short and long-term side effects. Overall, 100 patients consecutively admitted at the European Institute of Oncology (IEO) at the Division of Medical Senology will be enrolled; 50 patients with metastatic breast cancer will be exposed to the DSS and machine learning web application for 3 months (experimental group), and 50 patients will not be exposed to the intervention (control group). Each participant will fill a weekly medication diary and a set of standardized self-reports evaluating psychological and quality of life variables (Adherence Attitude Inventory, Beck Depression Inventory-II, Brief Pain Inventory, 13-item Sense of Coherence scale, Brief Italian version of Cancer Behavior Inventory, European Organization for Research and Treatment of Cancer Quality of Life 23-item Breast Cancer-specific Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 8-item Morisky Medication Adherence Scale, State-Trait Anxiety Inventory forms I and II, Big Five Inventory, and visual analogue scales evaluating risk perception). The 3 assessment time points are T0 (baseline), T1 (1 month), T2 (2 months), and T3 (3 months). This study was approved by the IEO ethics committee (R1786/22-IEO 1907). Results: The recruitment process started in May 2023 and is expected to conclude on December 2023. Conclusions: The contribution of machine learning techniques through risk-predictive models integrated into DSS will enable medication adherence by patients with cancer. Trial Registration: ClinicalTrials.gov NCT06161181; https://clinicaltrials.gov/study/NCT06161181 International Registered Report Identifier (IRRID): DERR1-10.2196/48852

[This corrects the article DOI: 10.2196/48852.].

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BACKGROUND Adherence to oral anticancer treatments is critical in the disease trajectory of patients with breast cancer. Given the impact of nonadherence on clinical outcomes and the associated economic burden for the health care system, finding ways to increase treatment adherence is particularly relevant. OBJECTIVE The primary end point is to evaluate the effectiveness of a decision support system (DSS) and a machine learning web application in promoting adherence to oral anticancer treatments among patients with metastatic breast cancer. The secondary end point is to collect a set of new physical, psychological, social, behavioral, and quality of life predictive variables that could be used to refine the preliminary version of the machine learning model to predict patients’ adherence behavior. METHODS This prospective, randomized controlled study is nested in a large-scale international project named “Enhancing therapy adherence among metastatic breast cancer patients” (Pfizer 65080791), aimed to develop a predictive model of nonadherence and associated DSS and guidelines to foster patients’ engagement and therapy adherence. A web-based DSS named TREAT (treatment adherence support) was developed using a patient-driven approach, with 4 sections, that is, Section A: Metastatic Breast Cancer; Section B: Adherence to Cancer Therapies; Section C: Promoting Adherence; and Section D: My Adherence Diary. Moreover, a machine learning–based web application was developed to predict patients' risk factors of adherence to anticancer treatment, specifically pertaining to physical status and comorbid conditions, as well as short and long-term side effects. Overall, 100 patients consecutively admitted at the European Institute of Oncology (IEO) at the Division of Medical Senology will be enrolled; 50 patients with metastatic breast cancer will be exposed to the DSS and machine learning web application for 3 months (experimental group), and 50 patients will not be exposed to the intervention (control group). Each participant will fill a weekly medication diary and a set of standardized self-reports evaluating psychological and quality of life variables (Adherence Attitude Inventory, Beck Depression Inventory-II, Brief Pain Inventory, 13-item Sense of Coherence scale, Brief Italian version of Cancer Behavior Inventory, European Organization for Research and Treatment of Cancer Quality of Life 23-item Breast Cancer-specific Questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, 8-item Morisky Medication Adherence Scale, State-Trait Anxiety Inventory forms I and II, Big Five Inventory, and visual analogue scales evaluating risk perception). The 3 assessment time points are T0 (baseline), T1 (1 month), T2 (2 months), and T3 (3 months). This study was approved by the IEO ethics committee (R1786/22-IEO 1907). RESULTS The recruitment process started in May 2023 and is expected to conclude on December 2023. CONCLUSIONS The contribution of machine learning techniques through risk-predictive models integrated into DSS will enable medication adherence by patients with cancer. CLINICALTRIAL ClinicalTrials.gov NCT06161181; https://clinicaltrials.gov/study/NCT06161181 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/48852