A Randomized Controlled Trial of the Feasibility and Preliminary Efficacy of a Texting Intervention on Medication Adherence in Adults Prescribed Oral Anti-Cancer Agents: Study Protocol

摘要

Aim: The aim of this study was to report a study protocol that examines feasibility, preliminary efficacy and satisfaction of a text message intervention on the outcome of medication adherence in adult patients prescribed oral anti-cancer agents.Background: Administration of oral anti-cancer agents occurs in the home setting, requiring patients to self-manage the regimen as prescribed. However, many barriers to medication adherence exist: regimens are often complex, with cycling of two or more medications; side effects of treatment; most cancer patients are older with comorbid conditions and competing demands; and cognitive decline and forgetfulness may occur. Research indicates patients miss nearly one-third of the prescribed oral anti-cancer agent dosages. Text message interventions have been shown to improve medication adherence in chronic conditions other than cancer. However, a majority of those patients were less than 50 years of age and most cancer patients are diagnosed later in life.Design: A two-group randomized controlled trial with repeated measures.Methods: Seventy-five adult patients newly prescribed an oral anti-cancer agent will be recruited (project funded in April 2013) from community cancer centres and a specialty pharmacy. Participants will be randomized to either a control group (n = 25; usual care) or an intervention group (n = 50; usual care plus text messages timed to medication regimen). Outcome measures include: medication adherence, feasibility and satisfaction with the intervention. Data will be collected over 8 weeks: baseline, weekly and exit.Discussion: Standardized text message intervention protocol and detailed study procedures have been developed in this study to improve medication adherence.