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

J Adv Nurs. 2015 Dec;71(12):2965-76. doi: 10.1111/jan.12714. Epub 2015 Jun 23.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01889511.

Keywords: cancer; intervention; mHealth; medication adherence; nursing; oral anti-cancer agent; randomized controlled trial; recruitment; text messaging.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / administration & dosage*
  • Cell Phone
  • Female
  • Humans
  • Male
  • Medication Adherence*
  • Middle Aged
  • Neoplasms / drug therapy*
  • Patient Satisfaction*
  • Self Care / methods*
  • Text Messaging*

Substances

  • Antineoplastic Agents

Associated data

  • ClinicalTrials.gov/NCT01889511