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

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.