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一项关于短信干预对口服抗癌药物成年患者用药依从性的可行性和初步疗效的随机对照试验:研究方案

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.

作者信息

Spoelstra Sandra L, Given Charles W, Sikorskii Alla, Coursaris Constantinos K, Majumder Atreyee, DeKoekkoek Tracy, Schueller Monica, Given Barbara A

机构信息

College of Nursing, Michigan State University, East Lansing, Michigan, USA.

Institute for Health Care Studies, Michigan State University, East Lansing, Michigan, USA.

出版信息

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.

摘要

目的

本研究旨在报告一项研究方案,该方案旨在检验针对口服抗癌药物的成年患者用药依从性结果的短信干预措施的可行性、初步疗效和满意度。

背景

口服抗癌药物在家中服用,要求患者按规定自行管理治疗方案。然而,用药依从性存在许多障碍:治疗方案通常很复杂,涉及两种或更多药物的循环使用;治疗有副作用;大多数癌症患者年龄较大,伴有合并症且有其他需求;还可能出现认知能力下降和健忘。研究表明,患者会错过近三分之一的口服抗癌药物规定剂量。短信干预已被证明可提高癌症以外慢性病的用药依从性。然而,这些患者大多数年龄小于50岁,而大多数癌症患者是在晚年被诊断出来的。

设计

一项采用重复测量的两组随机对照试验。

方法

将从社区癌症中心和一家专科药房招募75名新开具口服抗癌药物的成年患者(项目于2013年4月获得资助)。参与者将被随机分为对照组(n = 25;常规护理)或干预组(n = 50;常规护理加根据用药方案定时发送的短信)。结果指标包括:用药依从性、干预措施的可行性和满意度。数据将在8周内收集:基线、每周和结束时。

讨论

本研究制定了标准化的短信干预方案和详细的研究程序,以提高用药依从性。

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