An Electronic Health Intervention for Latina Women Undergoing Breast Cancer Treatment (My Guide for Breast Cancer Treatment): Protocol for a Randomized Controlled Trial

摘要

Background Among Latinas and Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. However, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer. Objective This paper aims to describe the procedures and methods of My Guide for Breast Cancer Treatment and the plans for conducting a multisite randomized controlled trial to investigate the feasibility and preliminary efficacy of this smartphone-based app for Latina women in active treatment for breast cancer. Methods Study participants will be randomized to the My Guide for Breast Cancer Treatment intervention or the enhanced usual care control condition for 12 weeks. Participants will have access to innovative features such as gamification via virtual awards to reinforce usage and an adaptive section that presents targeted material based on their self-reported concerns and needs. Using a stepped-care approach, intervention participants will also receive telecoaching to enhance their adherence to the app. Study outcomes and intervention targets will be measured at study enrollment (before randomization), 6 and 12 weeks after initial app use. General and disease-specific health-related quality of life (HRQoL) and symptom burden are the study’s primary outcomes, whereas anxiety, depression, fear of cancer recurrence, physical activity, and dietary intake are secondary outcomes. Results Recruitment began in August 2019 and is expected to be completed by August 2020. We expect to submit study results for publication by fall 2020. Conclusions My Guide for Breast Cancer Treatment has the potential to improve HRQoL and reduce symptom burden, and increase access to supportive care resources among Latina breast cancer patients.