title: Improving outcomes in cancer patients on oral anti-cancer medications using a novel mobile phone-based intervention: study design of a randomized controlled trial.
abstract: BACKGROUND
  The widespread and increasing use of oral anti-cancer medications has been ushered in by a rapidly increasing understanding of cancer pathophysiology. Furthermore, their popular ease of administration and potential cost savings has highlighted their central position in the health care system as a whole. These facts have heightened appreciation of the unique challenges associated with the use of oral anti-cancer medications; especially in the long-term use of these medications and the associated side effects that may impede optimal adherence to their use. Therefore, we developed ChemOtheRapy Assistant, CORA, a personalized mobile phone-based self-management application to help cancer patients on oral anti-cancer medications.
  
  
  OBJECTIVE
  Our objective is to evaluate the effect of CORA on adherence to oral anti-cancer medications and other clinically relevant outcomes in the management of patients with renal and prostate cancer.
  
  
  METHODS
  The study will be implemented as a 2-parallel group randomized controlled trial in 104 patients with renal or prostate cancer on oral anti-cancer medications over a 3-month study period. The intervention group will use CORA in addition to usual care for self-management while the control group will continue care as usual. Medication adherence will be measured objectively by a Medication Event Monitoring System device and is defined as the percentage of prescribed doses taken. We will also assess the effect of the intervention on cancer-related symptoms measured by the MD Anderson Symptom Inventory and unplanned hospital utilizations. Other outcomes that will be measured at study start, midpoint, and endpoint are health-related quality of life, cancer-related fatigue, and anxiety. Group differences in medication adherence will be examined by t tests or by non-parametric Mann-Whitney tests if the data are not normally distributed. Logistic regression will be used to identify potential predictors of adherence.
  
  
  RESULTS
  We expect to have results for this study before the end of 2016.
  
  
  CONCLUSIONS
  This novel mobile phone-enabled, multimodal self-management and educational intervention could lead to improvements in clinical outcomes and serve as a foundation for future mHealth research in improving outcomes for patients on oral anti-cancer medications.
authors.affiliation: Partners Healthcare Center for Connected Health, Boston, MA, United States. sagboola@partners.org.
authors.forename: Stephen
authors.identifier: http://orcid.org/0000-0002-2161-8091
authors.initials: S
authors.lastname: Agboola
authors.forename: Clare
authors.identifier: http://orcid.org/0000-0002-2425-7690
authors.initials: C
authors.lastname: Flanagan
authors.forename: Meghan
authors.identifier: http://orcid.org/0000-0002-0536-8344
authors.initials: M
authors.lastname: Searl
authors.forename: Aymen
authors.identifier: http://orcid.org/0000-0001-9693-8391
authors.initials: A
authors.lastname: Elfiky
authors.forename: Joseph
authors.identifier: http://orcid.org/0000-0002-7517-2291
authors.initials: J
authors.lastname: Kvedar
authors.forename: Kamal
authors.identifier: http://orcid.org/0000-0002-0122-8002
authors.initials: K
authors.lastname: Jethwani
keywords: cancer; mHealth; medication adherence; mobile application; oral anti-cancer medication; randomized controlled trial; self-care