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An Electronic Health Intervention for Latina Women Undergoing Breast Cancer Treatment (My Guide for Breast Cancer Treatment): Protocol for a Randomized Controlled Trial
My Guide for Breast Cancer Treatment: Study Design and Protocol for an eHealth Intervention for Latina Women Undergoing Breast Cancer Treatment
Betina Yanez;
Sharon H. Baik;
Laura C. Bouchard;
Diana Buitrago;
Joanna Buscemi;
Francisco Iacobelli;
Alejandra Perez-Tamayo;
Precilla Fajardo;
Gabriela Serrano;
Judy Guitelman;
Frank J. Penedo
ABSTRACT
Background:
Among Latinas/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:
Objective:
This paper describes the procedures and methods of My Guide for Breast Cancer Treatment, as well as the plans for conducting a multisite, randomized controlled trial to investigate the feasibility and preliminary efficacy of this Smartphone-based application for Latina women in active treatment for breast cancer.
Methods:
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 application. Study outcomes and intervention targets will be measured at study enrollment (prior to randomization), six and 12 weeks after initial application use. General and disease-specific health-related quality of life (HRQoL) and symptom burden are the study’s primary outcomes; while anxiety, depression, fear of cancer recurrence, physical activity, and dietary intake are secondary outcomes.
Results:
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.
An Electronic Health Intervention for Latina Women Undergoing Breast Cancer Treatment (My Guide for Breast Cancer Treatment): Protocol for a Randomized Controlled Trial