Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial.

Importance: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence. Objective: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET. Design, Setting, and Participants: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year. Interventions: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team. Main Outcomes and Measures: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms. Results: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants. Conclusions and Relevance: This RCT found that a remote monitoring app with alerts to the patient's care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life. Trial Registration: ClinicalTrials.gov Identifier: NCT03592771.

Advancing Inclusive Research (AIR) Site Alliance: Facilitating the inclusion of historically underrepresented people in oncology and ophthalmology clinical research.

BACKGROUND: The Advancing Inclusive Research (AIR) Site Alliance is composed of clinical research centers that partner with Genentech, a biotechnology company, to advance the representation of diverse patient populations in its oncology and ophthalmology clinical trials, test recruitment, and retention approaches and establish best practices to leverage across the industry to achieve health equity. METHODS: Through a data-driven selection process, Genentech identified 6 oncology and 3 ophthalmology partners that focus on reaching historically underrepresented patients in clinical trials and worked collaboratively to share knowledge and explore original ways of increasing clinical study access for every patient, including sites co-creation of a Protocol Entry Criteria Guideline with inclusion principles. RESULTS: For patients, three publicly available educational videos about clinical trials were created in multiple languages. The AIR Site Alliance has also defined invoiceable services for sites to enhance patient support; this has been built into the new study budget templates for sustainability. For healthcare professionals (HCPs), the first-of-its-kind AIR Educational Program was developed to focus on identifying and addressing bias and engaging historically underrepresented patient populations in trials. The sites also co-created videos for HCPs and patients on why advancing inclusive research matters. Over 16 regional health equity symposia have been delivered for patients, HCPs, and community leaders. CONCLUSIONS: This AIR Site Alliance is a model for other site alliances, including Kenya, South Africa, the United Kingdom, and Canada. Such alliances will build a robust and sustainable research ecosystem that includes diverse patient groups and encourages change across the healthcare system.

Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial.

BACKGROUND: Cancer treatment requires substantial demands on patients and their caregivers. Mobile apps can provide support for self-management during oncology treatment, but few have been rigorously evaluated. METHODS: A 3-month randomized controlled trial was conducted at a large cancer center to evaluate the efficacy of an app (LivingWith®) that provides self-management support during cancer treatment on quality of life and health care utilization. Patients in chemotherapy treatment were randomized into the intervention (n = 113) and control group (n = 111). Intervention group participants agreed to use the app weekly for 3 months, and all participants completed a survey at enrollment and after 3 months to evaluate changes in quality of life and health care utilization. RESULTS: Retention rate was 75.4% with 169 participants completing the follow-up survey. The intervention group reported 0.74 fewer medical office visits (p = 0.043) and 0.24 fewer visits with a mental health professional (p = 0.061) during the 3 and month intervention compared with controls. There were no significant changes by study group in quality of life, or emergency room and urgent care visits. Among intervention participants, 75.3% reported using the app and on average, used it 11.7 times during the 3-month intervention. Reasons for not using the app among intervention participants included lack of time, lack of interest in apps, and usability challenges. CONCLUSIONS AND RELEVANCE: Apps are inexpensive and scalable tools that can provide additional support for individuals coping with complex cancer treatments. This trial provides evidence that a well-designed oncology support app used during chemotherapy resulted in fewer clinic visits. Still, nearly a quarter of participants randomized to the intervention arm reported never using the app due to personal preference and usability challenges, which points to future opportunities for calibrating target user population and improving user-centered design. CLINICALTRIALS: gov identifier: NCT04331678.

An examination of health care utilization during the COVID-19 pandemic among women with early-stage hormone receptor-positive breast cancer.

BACKGROUND: Women undergoing treatment for breast cancer require frequent clinic visits for maintenance of therapy. With COVID-19 causing health care disruptions, it is important to learn about how this population's access to health care has changed. This study compares self-reported health care utilization and changes in factors related to health care access among women treated at a cancer center in the mid-South US before and during the pandemic. METHODS: Participants (N = 306) part of a longitudinal study to improve adjuvant endocrine therapy (AET) adherence completed pre-intervention baseline surveys about their health care utilization prior to AET initiation. Questions about the impact of COVID-19 were added after the pandemic started assessing financial loss and factors related to care. Participants were categorized into three time periods based on the survey completion date: (1) pre-COVID (December 2018 to March 2020), (2) early COVID (April 2020 - December 2020), and later COVID (January 2021 to June 2021). Negative binomial regression analyses used to compare health care utilization at different phases of the pandemic controlling for patient characteristics. RESULTS: Adjusted analyses indicated office visits declined from pre-COVID, with an adjusted average of 17.7 visits, to 12.1 visits during the early COVID period (p = 0.01) and 9.9 visits during the later COVID period (p < 0.01). Hospitalizations declined from an adjusted average 0.45 admissions during early COVID to 0.21 during later COVID, after vaccines became available (p = 0.05). Among COVID period participants, the proportion reporting changes/gaps in health insurance coverage increased from 9.5% participants during early-COVID to 14.8% in the later-COVID period (p = 0.05). The proportion reporting financial loss due to the pandemic was similar during both COVID periods (34.3% early- and 37.7% later-COVID, p = 0.72). The proportion of participants reporting delaying care or refilling prescriptions decreased from 15.2% in early-COVID to 4.9% in the later-COVID period (p = 0.04). CONCLUSION: COVID-19 caused disruptions to routine health care for women with breast cancer. Patients reported having fewer office visits at the start of the pandemic that continued to decrease even after vaccines were available. Fewer patients reported delaying in-person care as the pandemic progressed.

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.