Home-Based Treatment for Chronic Pain Combining Neuromodulation, Computer-Assisted Training, and Telemonitoring in Patients With Breast Cancer: Protocol for a Rehabilitative Study
Authors: Conti Lorenzo , Marzorati Chiara , Grasso Roberto , Ferrucci Roberta , Priori Alberto , Mameli Francesca , Ruggiero Fabiana , Pravettoni Gabriella 
Published: September 2023

Background
Chronic pain is a disabling symptom frequently reported in patients with breast cancer with a prevalence ranging from 25% to 60%, representing a major health issue. It has negative consequences on health status, causing psychological distress and affecting quality of life. Furthermore, the clinical management of chronic pain is often inadequate, and many patients do not benefit from the administration of pharmacological treatments. Alternative therapeutic options have been implemented to improve the psychophysical well-being of patients, including neuromodulation and complementary interventions.

Objective
We aimed to investigate the effectiveness of a home care strategy combining computerized rehabilitation, transcranial direct current stimulation (tDCS), and remote telemonitoring via a web-based platform in patients with breast cancer suffering for chronic pain.

Methods
A web-based structured survey aimed at monitoring chronic pain and its effect on psychological functions will be delivered to patients with breast cancer through social media and email. In total, 42 patients with breast cancer affected by chronic pain will be recruited during the medical screening visit. The patients will be randomly divided into 3 treatment groups that will carry out either tDCS only, exercise therapy only, or a combination of both over a 3-week period. All the treatments will be delivered at the patients’ home through the use of a system including a tablet, wearable inertial sensors, and a tDCS programmable medical device. Using web-based questionnaires, the perception of pain (based on the pain self-efficacy questionnaire, visual analogue scale, pain catastrophizing scale, and brief pain inventory) and psychological variables (based on the hospital and anxiety depression scale and 12-item short form survey) will be assessed at the beginning of treatment, 1 week after the start of treatment, at the end of treatment, 1 month after the start of treatment, and 3 months after the start of treatment. The system’s usability (based on the mobile app rating scale and system usability scale) and its involvement in the decision-making process (based on the 9-item shared decision-making questionnaire) will be also evaluated. Finally, at the end of the treatment, a digital focus group will be conducted with the 42 patients to explore their unexpressed needs and preferences concerning treatment.

Results
The study project is scheduled to start in June 2023, and it is expected to be completed by August 2025.

Conclusions
We expect that the combination of tDCS and telemedicine programs will reduce pain perceived by patients with breast cancer and improve their mental well-being more effectively than single interventions. Furthermore, we assume that this home-based approach will also improve patients’ participation in routine clinical care, reducing disparities in accessing health care processes. This integrated home care strategy could be useful for patients with breast cancer who cannot find relief from chronic pain with pharmacological treatments or for those who have limited access to care due to poor mobility or geographical barriers, thus increasing the patients’ empowerment and reducing health care costs.

International Registered Report Identifier (IRRID)
PRR1-10.2196/49508