BACKGROUND

Patients prescribed oral chemotherapy receive less support for adherence and monitoring of symptoms from oncology clinicians than do patients prescribed traditional infusion chemotherapy, resulting in poor adherence, lower-quality care, and worse disease outcomes. No theory-based, efficacious interventions exist to promote adherence and symptom monitoring for patients prescribed oral chemotherapy.

OBJECTIVES

The primary aims of this study were to (1) develop a patient-centered, smartphone mobile application (app) to facilitate adherence to oral chemotherapy and symptom management for patients with cancer; and (2) test the effect of the app on improving adherence to oral chemotherapy, symptoms, quality of life (QOL), and quality of care in a randomized controlled trial (RCT).

METHODS

A multidisciplinary research team worked with key stakeholders to develop the mobile app, soliciting feedback on app content, usability, and patient-centeredness from 4 groups: patients/families (n = 8); oncology clinicians (n = 8); cancer practice administrators (n = 8); and representatives from the health system, community, and society (n = 8), as well as patients (n = 10) and oncology clinicians (n = 8) from the Massachusetts General Hospital. Then, from February 18, 2015, to October 31, 2016, 181 patients with diverse malignancies prescribed oral chemotherapy enrolled in an RCT to receive the mobile app intervention or standard oncology care. The primary outcomes were adherence and self-reported symptoms and QOL. Adherence was measured by the Medication Event Monitoring System Cap (MEMSCap) and by self-report. The secondary outcomes were patient perceptions of quality of care and utilization (ie, hospitalizations and emergency department visits). Patients completed the self-report questionnaires at baseline before randomization and at 12 weeks.

RESULTS

Feedback from stakeholders and patient participants greatly informed intervention development and showed that the app was perceived as useful and acceptable. The final app incorporated features including a treatment plan, reminder system, symptom reporting modules, and patient resources. Patient-reported data were transmitted to the oncology team via HIPAA-compliant email on a weekly basis. The mobile app intervention group and control group did not differ over time with respect to the primary outcomes of adherence, self-reported symptoms, and overall QOL, or in the secondary outcomes of quality of care and utilization. In examining specific domains of QOL, patients in the mobile app group had a smaller reduction in social well-being over time (M = 1.67; SE, 0.74; = 5.13; = .025; 95% CI, −3.12 to −0.21). Subgroup analyses showed that patients with poor self-reported adherence and high anxiety at baseline who were randomized to the app had improved MEMSCaps adherence rates compared with the standard care group. Finally, older patients randomized to the app reported improved QOL compared with those receiving standard care.

CONCLUSIONS

Feedback from stakeholders and patient partners was instrumental in optimizing relevancy, feasibility, and acceptability of the study methods and app intervention. Across all patients, the mobile app was not efficacious in improving adherence or symptoms. However, patients at greater risk for nonadherence may benefit.

LIMITATIONS

Use of daily MEMSCap as the primary study outcome may have raised participant awareness of adherence across both study groups, perhaps diminishing intervention effects. Additionally, generalizability of study findings is limited due to the restricted diversity of this well-educated sample at an academic institution.