Cognitive Rehabilitation and Psychosocial Intervention Through a Stepped Digital Ecosystem in Breast Cancer: A Randomized Clinical Trial.

Brief Summary

Detailed Description

BACKGROUND Breast cancer (BC) diagnoses have increased, and while survival rates have improved, the focus on the quality of life (QoL) for survivors, including cognitive function, has intensified. Cancer-related cognitive impairment (CRCI) is recognized, encompassing objective deficits and subjective experiences. Various factors, such as chemotherapy agents, stress, and psychological factors, influence CRCI. Non-pharmacological treatments, including psychoeducational interventions and cognitive training, have shown promise. However, there are barriers in oncological settings, including a lack of awareness and standardized protocols. Current developed technologies like eHealth offer solutions, yet studies addressing cognitive care in eHealth psychosocial interventions are limited. This study aims to assess the ICOgnition digital intervention's effectiveness in improving BC patients' subjective and objective cognitive symptoms. It also explores factors influencing cognitive function, the effectiveness of online cognitive testing, and the gap between objective and subjective deficits. The study will also evaluate the feasibility and cost-effectiveness of ICOnnecta't + ICOgnition interventions to provide insights into their scalability and sustainability. The hypothesis suggests that the ICOnnecta't-enhanced intervention (ICOgnition) will outperform ICOnnecta't alone in improving both subjective and objective cognitive functioning in BC patients. METHODS/DESIGN The trial is conducted at the Catalan Institute of Oncology (ICO) in Hospitalet de Llobregat. Patients meeting inclusion criteria are referred by the Breast Functional Unit to the ICOnnecta't Program team. Eligible candidates receive detailed study information via a call and, if willing to participate, schedule an in-person appointment at the ICOnnecta't Space. Researchers explain the study, obtain informed consent, and utilize the secure web platform REDCap for questionnaires. Assessments occur at baseline (T1), 3 months (T2), 6 months (T3), and 12 months (T4). Recruitment starts in December 2023 and spans a year. Breast cancer patients will be randomly assigned to one of the two treatment groups using REDCap, employing a simple randomization method (1:1). o Study Sample The study will include 176 female breast cancer patients in the acute survival phase from ICO Hospitalet. o Statistical Analysis: Primary Outcome Analysis The study will employ independent Linear Mixed Models with patients clustered to analyze cognitive outcomes between the two intervention groups: digital stepped psychosocial care vs. digital stepped psychosocial care + cognitive module. Subjective Cognition (FACT-Cog) and Objective Cognition (Neurocognitive Index) will be separately assessed, adjusting for age and education. Descriptive statistics, effect sizes, and 95% confidence intervals will be reported. Secondary Outcome Analysis Linear Mixed Models will be used to analyze secondary outcomes (e.g., depression, anxiety, distress, quality of life) following the same procedure. Mediation analysis will explore emotional distress and posttraumatic stress as mediators between interventions and cognitive responses. Other Pre-Specified Outcome Analyses * Discrepancy between Objective and Subjective Measures: Standardized values will be compared using ICC, Bland-Altman Plot, and linear regression to identify variables explaining discrepancies. * Clusters of Cognitive Impairment: Cluster analysis will identify participant groups with similar cognitive profiles and explore differences in demographics, clinical variables, and treatment response. * Cognitive Assessment Optimization: The equivalence of online vs. paper and pencil tests in detecting cognitive impairment will be tested, and the most sensitive test for CRCI detection will be explored. * Cost-Utility Analysis: This analysis expresses the cost-effectiveness of interventions in terms of cost per Quality-Adjusted Life Year (QALY) gained, a common measure used in healthcare decision-making. * Statistical Power: Utilizing GLIPMPSE, the study has a power of 0.802 with a significance level of 0.05. With 176 subjects (88 in each group), the study can detect a significant difference of 5.9 units, assuming a common standard deviation of 15, based on previous research findings (Bell et al., 2018). o Discussion The ICOgnition intervention offers a promising and comprehensive approach to address cognitive difficulties in newly diagnosed breast cancer patients. By integrating digital psychosocial support, personalized cognitive training, and psychoeducational resources, this intervention aims to enhance cognitive function and improve the overall quality of life for patients. Notably, its potential impact could extend to individuals facing cognitive challenges in various medical conditions beyond breast cancer. However, challenges related to implementation, resource allocation, patient adherence, and economic evaluation need careful consideration to ensure the intervention's effectiveness in real-world settings. If successfully implemented, ICOgnition could serve as a valuable model for addressing cognitive impairments, fostering a better understanding of cognitive challenges in medical settings, and enhancing patients' overall well-being.

Primary Outcomes

Secondary Outcomes

• Intervention Satisfaction(Assessment will be conducted at 3 months)
• Change in Medication adherence(Assessment will be conducted at baseline and at 3 months, 6 months and 12 months)
• Change in emotional distress(Assessment will be conducted at baseline and at 3 months, 6 months and 12 months)
• Post-traumatic Stress(Assessment will be conducted at baseline and at 12 months)
• Changes in Work role functioning(Assessment will be conducted at baseline and at 12 months)
• Change in Quality of Life(Assessment will be conducted at baseline and at 12 months)
• Changes in Health Literacy(Assessment will be conducted at baseline and at 12 months)
• ICOnnecta't / ICOgnition App Usability(Assessment will be conducted at 3 months)