THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care.

BACKGROUND: Women with hormone receptor-positive, early-stage breast cancer who adhere to adjuvant endocrine therapy (AET) reduce the risk of cancer recurrence and mortality. AET, however, is associated with adverse symptoms that often result in poor adherence. We applied participatory action research (PAR) principles to conduct focus groups and interviews to refine and enhance a web-enabled app intervention that facilitates patient-provider communication about AET-related symptoms and other barriers to adherence. METHODS: We conducted four focus groups with women with early-stage breast cancer on AET (N=28), stratified by race (Black and White) and length of time on AET (<6 months and >6 months), to determine preferences and refine the app-based intervention. A fifth mixed-race focus group was convened (N=6) to refine THRIVE app content using high-fidelity mock-ups and to develop new, tailored feedback messages. We also conducted interviews with oncology nurses (N=5) who participated in the THRIVE randomized controlled trial. RESULTS: Participants reported preferences for weekly reminder messages to use the THRIVE app, a free-text option to write in AET-related symptoms, and app aesthetics. Other requested app features included: a body map for identifying pain, sleep and dental problems on the symptom list, a dashboard, tailored feedback messages, and information about social support resources. Participants also developed new intervention messages, decided which messages to keep, and edited language for appropriateness and sensitivity. They also discussed the type of electronic pill monitor and incentive plan to be used in the intervention. Nurses reported THRIVE alerts integrated seamlessly into their clinical workflow and increased patient-provider communication, facilitating quicker response to patients' reported symptoms. Nurses reported no negative feedback or usability concerns with the app. CONCLUSIONS: THRIVE app content reflects researchers' partnership with a racially diverse sample of breast cancer survivors and healthcare providers and adherence to participatory design by incorporating patient-requested app features, app aesthetics, and message content. The app has the potential to improve AET adherence and quality of life among breast cancer survivors and reduce disparities in mortality rates for Black women by facilitating communication with healthcare providers.

"Nobody Will Tell You. You've Got to Ask!": An Examination of Patient-Provider Communication Needs and Preferences among Black and White Women with Early-Stage Breast Cancer.

Patient-provider communication is a critical component of healthcare and is associated with treatment quality and outcomes for women with breast cancer. This qualitative study examines similarities and differences in patient perspectives of communication needs between Black and White breast cancer survivors. We conducted four focus groups (N = 28) involving women with early-stage breast cancer on adjuvant endocrine therapy (AET), stratified by race and length of time on AET (< 6 months and >6 months). Each group was moderated by a race-concordant moderator and analyzed by emergent themes. Participants expressed common patient-provider communication needs, namely increased sensitivity from oncologists during the initial cancer diagnosis, personalized information to facilitate treatment decisions, emotional support during the transition from active treatment to maintenance, and rapid provider responses to mobile app-based queries. Communication differences by race also emerged. Black women were less likely than White women to describe having their informational needs met. White women praised longstanding relationships with providers, while Black women shared personal stories of disempowered interactions and noted the importance of patient advocates. White women more often reported privacy concerns about technology use. Unlike White women, Black women reported willingness to discuss sensitive topics, both online and offline, but believed those discussions made their providers feel uncomfortable. Early-stage breast cancer patients on AET, regardless of race, have similar needs for patient-centered communication with their oncologists. However, Black women were more likely to report experiencing poorer communication with providers than White women, which may be improved by technology and advocates.

THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer.

BACKGROUND: Long-term use of adjuvant endocrine therapy (AET) among women with early-stage, hormone receptor-positive breast cancer significantly reduces the risk of hospitalizations, cancer recurrence, and mortality. AET is associated with adverse symptoms that often result in poor adherence. A web-enabled app offers a novel way to communicate and manage symptoms for women on AET. In a region with significant racial disparities in breast cancer outcomes, our study tests the impact of a web-enabled app that collects and transmits patient-reported symptoms to healthcare teams to facilitate timely and responsive symptom management on medication adherence. METHODS: In this randomized controlled trial, we randomize 300 patients initiating AET to one of three arms: 1) an "App" group (n = 100) that receives weekly reminders to use the THRIVE study app; 2) an "App+Feedback" group (n = 100) that receives weekly reminders and tailored feedback based on their use of the app; or 3) a "Usual Care" group (n = 100) that receives usual care only. Participants are stratified by race: 50% White and 50% Black. The duration of the intervention is six months following enrollment, and outcomes are assessed at 12-months. The primary outcome is adherence, which is captured using an electronic monitoring pillbox. Secondary outcomes include symptom burden, quality of life, self-efficacy for managing symptoms, and healthcare costs. We also evaluate the impact of the intervention on racial disparities in adherence. Data are derived from three sources: electronic health record data to capture treatment changes, healthcare utilization, and health outcomes; self-report survey data related to adherence, symptom burden, and quality of life; and an electronic medication monitoring device that captures adherence. DISCUSSION: A successful web-enabled intervention could be disseminated across systems, conditions, and populations. By evaluating the impact of this intervention on a comprehensive set of measures, including AET adherence, patient outcomes, and costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient care experience. TRIAL REGISTRATION: NCT03592771. Prospectively registered on July 19, 2018.

A qualitative exploration of race-based differences in social support needs of diverse women with breast cancer on adjuvant therapy.

OBJECTIVE: Social support is a critical component of breast cancer care and is associated with clinical and quality of life outcomes. Significant health disparities exist between Black and White women with breast cancer. Our study used qualitative methods to explore the social support needs of Black and White women with hormone receptor-positive breast cancer on adjuvant endocrine therapy (AET). METHODS: We conducted four focus group (FG) interviews (N = 28), stratified by race (ie, Black and White) and time on AET. FGs were audiotaped, transcribed, and analyzed according to conventions of thematic analysis. RESULTS: Participants noted the importance of having their informational and emotional social support needs met by friends and family members. White participants reported support provided by others with breast cancer was crucial; Black women did not discuss other survivors as part of their networks. Notably, both White and Black participants used the FG environment to provide experiential social support to each other. CONCLUSIONS: White participants noted that having other breast cancer survivors in their support network was essential for meeting their social support needs. However, Black participants did not reference other breast cancer survivors as part of their networks. Cancer centers should consider reviewing patients' access to experiential support and facilitate opportunities to connect women in the adjuvant phase.