Among Latinas/Hispanics (henceforth referred to as Latinas), breast cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths [1]. Compared with non-Latina breast cancer survivors (BCSs), Latina BCSs report multiple disparities including poorer health-related quality of life (HRQoL), greater symptom burden, greater cancer-related psychosocial needs [2-4], less breast cancer knowledge, and more dissatisfaction with information related to breast cancer care [5]. Prior studies show that poorer HRQoL is related to lower levels of adherence to disease surveillance and adjuvant treatment [6,7], and interventions designed to improve HRQoL specifically for Latina BCSs can improve adherence to posttreatment care and health outcomes [2,8,9]. However, given the documented disparities beyond HRQoL, interventions targeting Latina BCSs must also provide education about cancer-related symptoms and evidence-based tools to manage symptoms and associated distress.

To address poor HRQoL among Latina BCSs, our team previously developed and pilot tested My Guide, a smartphone-based app designed specifically for Latina BCSs to improve HRQoL and reduce symptom burden after completing primary breast cancer treatment [10]. The initial My Guide app is available in both English and Spanish, expanding its reach to underserved Latina BCSs. Preliminary findings show that My Guide is feasible for Latina BCSs to use (eg, acceptable app usage and high user satisfaction) [11]. However, many of our participants noted that they wished that they had access to the app content during treatment.

To date, few interventions have been developed to meet the needs of Latina women undergoing active treatment for breast cancer [12]. There is a critical need for culturally informed interventions designed to address the supportive care needs of Latina women in active treatment, particularly for primarily Spanish-speaking women [3]. Given the high rates of internet and smartphone use documented among US Latinos [13], electronic health–based interventions may capitalize on opportunities to provide scalable resources to Latinas undergoing active treatment while limiting participant burden [14-17].

In light of the limited technology-assisted interventions specifically designed for Latina women undergoing active treatment for breast cancer, more studies are needed to establish the feasibility of smartphone-based interventions for Latinas during active cancer treatment [12]. In response to the feedback from our participants enrolled in the My Guide pilot study and the dearth of literature regarding interventions for Latina breast cancer patients actively undergoing treatment, we have developed My Guide for Breast Cancer Treatment. The purpose of this paper is to describe the procedures and methods of this follow-up intervention. Guided by Bowen et al’s conceptual model of feasibility studies [18], we describe the plans for conducting a multisite, randomized controlled trial (RCT) to establish the feasibility of My Guide for Breast Cancer Treatment for Latina women undergoing breast cancer treatment.

We hypothesize that Latina women will find My Guide for Breast Cancer Treatment feasible for accessing information related to breast cancer and its treatment and for learning strategies to improve symptom management, self-efficacy, communication, and stress. We also hypothesize that women randomized to the My Guide for Breast Cancer Treatment app will have better primary outcomes (ie, HRQoL) and secondary outcomes (ie, symptom burden, anxiety, depressive symptoms, and distress) than women randomized to an enhanced usual care control condition.

This RCT is designed to assess the preliminary feasibility and efficacy of the My Guide for Breast Cancer Treatment smartphone app for improving HRQoL and symptom burden in Latina women receiving treatment for primary breast cancer. After providing informed consent, participants will be randomized to the My Guide for Breast Cancer Treatment intervention condition or to the enhanced usual care control condition. Randomization will be stratified by recruitment site and language (ie, English and Spanish). Participants randomized to the My Guide for Breast Cancer Treatment intervention condition will have access to the smartphone app for 12 weeks and will be encouraged to use the app for 1.5 hours each week. The My Guide for Breast Cancer Treatment app is accessible on all smartphones (eg, Apple and Samsung) as well as tablets and computer websites. It is available in both English and Spanish, and participants will be provided the app in their preferred language. Participants randomized to the My Guide for Breast Cancer Treatment intervention condition will be oriented to the app and instructed to use it for 1.5 hours each week for a duration of 12 weeks. A 12-week intervention timeframe was selected based on previous studies indicating benefits in HRQoL and symptom burden outcomes after 10 weeks of behavioral interventions and the expected length of adjuvant treatments [19-21]. Thus, we believe that 12 weeks will allow sufficient time for participants to access and benefit from the My Guide for Breast Cancer Treatment app content. Intervention participants will also be assigned a bilingual telecoach for the duration of the study. Using a stepped-care approach [22], intervention participants will receive weekly telecoaching calls based on their level of adherence to the recommended app usage.

Study outcomes and intervention targets will be measured at study enrollment and before randomization (T1), 6 weeks postbaseline (T2), and 12 weeks postbaseline (T3). All assessment time points will consist of measures assessing our primary outcomes, intervention targets, and secondary outcomes. In addition, all participants will complete a sociodemographic questionnaire at T1, and participants randomized to the intervention condition will be asked to complete an exit survey at T3. Assessments are estimated to take approximately 35 min to complete. Participants randomized to the intervention condition will also be asked to complete brief, 3-min, weekly questionnaires throughout the course of the 12-week intervention. See section Data Collection and Outcomes for greater detail. Participants will be compensated US $100 for their participation in the study and receive partial reimbursement for telephone data usage plans. Participants without an internet-enabled device will be provided one for the duration of the study. All study procedures and assessments have been approved by the institutional review board (IRB) of record for this multisite study (Northwestern IRB).

Participants will be 60 Latina women who have been diagnosed with stage I-IIIA breast cancer, have completed surgery (eg, mastectomy and lumpectomy), and are actively receiving adjuvant treatment for breast cancer (eg, chemotherapy, radiation, and biologic therapy). We will enroll participants from the Robert H. Lurie Comprehensive Cancer Center at Northwestern Memorial Hospital, the University of Illinois Health System, and various community-based support groups sponsored by ALAS-WINGS, a Chicago-based nonprofit organization for Latina breast cancer patients.

We will identify participants through screening of the electronic medical record (EMR), and final determinations for study eligibility will be made based on a self-report questionnaire via telephone interview. To be included in the study, participants must (1) be female, because male breast cancer patients represent less than 1% of the breast cancer cases; (2) have a diagnosis of stage I-IIIA breast cancer; (3) have completed surgery for breast cancer; (4) be within any timepoint of the adjuvant treatment trajectory for breast cancer (eg, chemotherapy, radiation, surgery, and biologic therapy); (5) be at least 18 years of age; (6) be able to speak and read English or Spanish; (7) be able to provide informed consent; and (8) self-identify as Hispanic/Latina ethnicity. Participants will be excluded from the study if they (1) have a hearing, motor, visual, or voice impairment that would preclude completion of study procedures; (2) have been diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, or any other diagnosis for which study participation would be inappropriate or dangerous; (3) endorse suicidal ideation, plan, or intent; (4) endorse illicit substance or alcohol dependence; or (5) have been diagnosed with dementia. Patients with metastatic disease will not be included in this study, as they have more extensive treatment regimens and substantially different needs relative to patients with earlier stages of breast cancer.

Eligible participants who provide informed consent will be individually randomized using a 1:1 ratio to either the intervention condition (My Guide for Breast Cancer Treatment) or the control condition (enhanced usual care) for a total of 3 months.

Consistent with past research, the feasibility of My Guide for Breast Cancer Treatment intervention will be evaluated by assessing the acceptability and demand of the app [18]. Acceptability of the app will be assessed at T3 using a previously tested app satisfaction questionnaire [20] that measures the usefulness, satisfaction, learnability, and usability of My Guide for Breast Cancer Treatment. Above average scores will be considered acceptable. Demand will be measured with study recruitment, retention, and participant use of My Guide for Breast Cancer Treatment (eg, frequency of log-ins, time spent using the app, and content accessed). Recruitment and retention rates of 70% or more will be considered acceptable based on our prior work and published studies [20,41,42].

All measures will be administered in each participant’s preferred language. For assessments completed in Spanish, we will use measures that have either been previously translated to Spanish and validated or measures that were translated to Spanish for this study by IRB-approved translators.

Participants will complete a self-report sociodemographic questionnaire at T1 including questions related to age, racial background, Latina ancestry, income, employment, relationship status, educational attainment, years living in the United States, and subjective social status using the MacArthur scale [43]. Participants will self-report clinical information including time since breast cancer diagnosis and surgery, stage of diagnosis, type of surgery, current treatment regimen (eg, chemotherapy and radiation), additional medications, medical comorbidities (assessed using the Charlson Comorbidity Index [44]), and past or current psychiatric diagnoses. Financial toxicity will be measured using Comprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy [45]. All self-reported medical- and disease-related information will be verified via medical chart review.

Descriptive statistics will be used to characterize the overall sample, each condition, and study acceptability and demand. To examine preliminary differences in feasibility between study conditions, we will use the chi-square test, Fisher exact test, and nonparametric Mann-Whitney U test for non-normal data, as appropriate. With 30 participants per study condition, there will be 80% power to detect approximately one-half SDs, assuming a 2-tailed test and a type I error rate of 5%. All power calculations were run using PROC POWER in SAS version 9.4.

For each study outcome, average changes from pre intervention to post intervention will be calculated via means (SD) and 95% CIs, and the mean changes within study condition will be converted to effect sizes. An analysis of covariance approach will be used to examine differences between the intervention and control conditions in follow-up scores, after adjusting for baseline score. Established cut-offs will also be referenced for clinically meaningful differences for the FACT-B and FACT-B subscales to identify ranges and patterns of changes in scores across conditions from baseline to follow-up.

All study data will be managed and stored in Research Electronic Data Capture (REDCap), a secure Web-based research data management system hosted at Northwestern University. All IRB-approved research team members will have access to REDCap. REDCap will be used to organize EMR data and to administer all study questionnaires. The My Guide for Breast Cancer Treatment administrative interface will capture participants’ app usage and weekly questionnaire data, which will be uploaded to REDCap to centralize all research information. Once all data are collected, the data will be imported into SPSS for data cleaning and analysis.

The aim of the My Guide for Breast Cancer Treatment study is to improve HRQoL and reduce symptom burden among Latina women undergoing active treatment for breast cancer. To the best of our knowledge, this is the first bilingual, smartphone-based supportive care app for Latinas women with breast cancer in active treatment. Providing a supportive and behavioral intervention that focuses on cancer treatment education and self-management during active treatment has the potential to improve patient-reported outcomes and clinical outcomes during active treatment and into survivorship.

Compared with the first version of the My Guide smartphone app, our team implemented substantial changes in this version of the My Guide for Breast Cancer Treatment app. Adding an adaptive functionality offers My Guide for Breast Cancer Treatment users a more personalized approach to delivering the intervention content, and the addition of a gamification via virtual ribbons, medals, and trophies provides users with encouragement to sustain use of the app across the length of the study. Unlike our first My Guide study [10] that included a 2-month longitudinal trial, we have extended the time frame of this study to 3 months to accommodate the expected time frame during which our study participants will be receiving adjuvant treatment. These strategic changes make this version of the My Guide for Breast Cancer Treatment app and this study design better suited for women in active treatment.

A few limitations of the study protocol warrant discussion. First, because the focus of this study is on breast cancer patients who are in active treatment, long-term cancer survivors will not be enrolled in this study, which limits study generalizability. In addition, women who are preparing for surgery will not be included in this study. However, My Guide for Breast Cancer Treatment does include a focus on the postsurgical recovery phase such as information related to postsurgical symptoms (eg, pain and lymphedema) and information related to reconstructive surgery.

There are several areas for future directions. If found feasible, future studies should establish the efficacy of My Guide for Breast Cancer Treatment across a nation-wide, heterogeneous sample of Latina women diagnosed with breast cancer. Currently, the My Guide for Breast Cancer Treatment app does not include any social media aspects; the potential benefit of adding a social media component to My Guide for Breast Cancer Treatment may be another important direction for future iterations of the app. In addition, given the multiple components of this feasibility trial (ie, app, telecoaching, and SMS text messaging), another important future direction will be to disentangle the effects of each component of the intervention on study outcomes.

Findings from this second study of the My Guide for Breast Cancer Treatment app are expected to contribute to the literature by establishing the efficacy of a smartphone-delivered intervention to enhance self-management during breast cancer treatment for improving HRQoL and symptom burden among Latina patients. Given the technology-based delivery of this app, the My Guide for Breast Cancer Treatment app has the potential for nation-wide scalability and therefore can increase access to supportive care resources among Latina breast cancer patients.