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 (Preprint)
Authors: Fietta Valentina , Rizzi Silvia , Gios Lorenzo , Selmi Silvana , De Luca Chiara , Pederiva Lucia , Poggianella Stefania , Pavesi Maria Chiara , Campregher Monica , Lazzeri Silvia , Cantarelli Sara , Purgato Marianna , Barbui Corrado , Navarin Nicolò , Gabrielli Silvia , Monaro Merylin , Forti Stefano , Ferro Antonella 
Published: September 2024

BACKGROUND

Emerging digital tools play an innovative and key role in supporting women's psychological well-being when facing different issues and phases of oncological disease. The development and implementation of digital interventions, such as chatbots and virtual coaches integrated into smartphone apps, have become increasingly evident as valuable resources to support these women's mental health.

OBJECTIVE

The aim of the present paper is to depict the research protocol design of the pilot study. This proof-of-concept research is designed to assess the feasibility, acceptability, and utility of an ACT-based stress management mobile app. Specifically, this study primarily examines the feasibility of utilizing a virtual coach, ALBA, to enhance women's psychological well-being during breast cancer through five ACT-based coaching sessions. This intervention is a chat-bot based version of the WHO-validated intervention Self-Help+ for stress management. Additionally, the study will investigate the impact of this intervention in terms of the level of psychological well-being achieved.

METHODS

A sample size of fifty participants has been identified to fulfil 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's characteristics, developed to be psychoeducational and accessible by a multidisciplinary team and in line with the SH+ WHO protocol, aim to reach significant outcomes regarding the usability and engagement of women with ALBA and its sessions. Furthermore, an enhancement in psychological well-being and quality of life of users is expected. The analysis of the data collected in this pilot study will adopt a descriptive perspective focused on evaluating qualitatively and quantitatively the attainment of the study objectives.

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. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout breast cancer pathology.

CLINICALTRIAL

The ethics committee of the APSS (Provincial Health Services Authority) approved this study under number A985 of 17/07/2024.