title: Pain management in cancer patients using a mobile app: study design of a randomized controlled trial.
abstract: BACKGROUND
  Despite the availability of effective medications and clinical guidelines for pain management, pain control is suboptimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a mobile phone application, ePAL, based on clinical guidelines to empower patients for cancer pain management by prompting regular pain assessments and coaching for self-management.
  
  
  OBJECTIVE
  The objective of this study is to evaluate the effect of a multidimensional mobile phone-based pain management application, ePAL, on controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic.
  
  
  METHODS
  The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a mobile phone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crisis, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy-General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations.
  
  
  RESULTS
  The study is still in progress. We hope to have results by the end of 2015.
  
  
  CONCLUSIONS
  The multidimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02069743; https://clinicaltrials.gov/ct2/show/NCT02069743 (Archived by WebCite at http://www.webcitation.org/6Qb65XGGA).
authors.affiliation: 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: Mihir
authors.identifier: http://orcid.org/0000-0003-4247-5314
authors.initials: M
authors.lastname: Kamdar
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: Lara
authors.identifier: http://orcid.org/0000-0002-8175-5725
authors.initials: L
authors.lastname: Traeger
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 pain; mHealth; mobile application; palliative care; randomized controlled trial; self care