A Chat-Bot Based Version of the WHO-validated Intervention Self-Help+ for Stress Management in Breast Cancer Patients: Protocol for a Pilot Feasibility Study

Background: Emerging digital tools play an innovative and key role in supporting women's psychological well-being during various stages and challenges of oncological disease. The development and adoption of digital interventions, including chatbots and virtual coaches within smartphone apps, are increasingly recognized as valuable resources for enhancing women's mental health. Objective: The aim of this paper is to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and perceived utility of a mobile app delivering an Acceptance-Commitment Therapy (ACT)-based stress management intervention. The intervention is delivered through ALBA ("A welL-Being Assistant"), a virtual coach embedded within the TreC Research platform-an m-health ecosystem designed to support research and digital health interventions. ALBA guides users through five coaching sessions tailored for women undergoing breast cancer treatment. The chatbot-delivered app is an adaptation of Self-Help+, a WHO-validated stress management intervention, and is provided in text, audio, and video formats. The intervention's potential impact on participants' psychological well-being is also explored. Methods: A convenience sample size of fifty participants will be identified to meet the study's objectives. Participant recruitment will be conducted among women accessing the Breast Unit care services of the Azienda Provinciale per Servizi Sanitari di Trento, adopting a convenience sampling approach. ALBA will interact with the participants for a total of six weeks. Specifically, there will be one coaching session per week, followed by weekly assigned ACT exercises to be performed between sessions. Results: The app is expected to demonstrate high usability and engagement, aligning with the WHO Self-Help+ protocol. Improvements in psychological well-being and quality of life are anticipated. Data from this pilot will be analyzed using both quantitative and qualitative methods, with a focus on assessing feasibility, acceptability, and perceived utility and usability in supporting women during breast cancer treatment. Conclusions: Existing literature indicates a promising role of new technologies in delivering validated mental health interventions, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. This pilot is expected to provide valuable insights on potential acceptability and usefulness of providing consistent, m-health psychoeducational support for women throughout the course of breast cancer.