Text Messaging to Improve Adherence to Oral Chemotherapy Agents

NCT01889511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-09-21

No results posted yet for this study

Summary

The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale health-related research project on text messages to improve adherence to oral chemotherapy agents. Michigan State University College of Nursing has not been a major recipient of National Institute of Health grant funding. As a result, the overall objective of this proposal is to strengthen the research environment in the College of Nursing so that it can develop into a significant health-related scientific research enterprise. This project would involve undergraduate and graduate students, and thus, generate student interest in research as a career. The importance of the research planned for this proposal is as follows. More than 50 oral chemotherapy agents in pill form are currently on the market, with projections that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. To date, empirical research in the area of improving adherence to oral agents is underdeveloped. The goal of this research is to improve adherence to oral chemotherapy agents through a technology based strategy, tailored SMS text messages. This prospective randomized controlled trial will examine the feasibility, acceptability, and satisfaction with a 3-week tailored text message intervention for oral agent adherence. Descriptive statistics, generalized linear modeling, and generalized estimating equations will be used for analysis. In this proposal, preliminary data will be collected to examine efficacy of the text message intervention to promote adherence to oral agents. Data will then be used to further inform the development of an intervention to improve adherence to oral agents for an R01 application to conduct a larger randomized trial to test this innovative intervention. This study can have a transformative impact on oral agent adherence by developing a technology-based strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This type of novel intervention also has the potential to transform and impact many other ill populations that require adherence to a medication regimen.

Conditions

Interventions

BEHAVIORAL

Intervention group - texts

Patients will be instructed to respond to the text message by sending a text stating if the oral agent was "taken". If there is no response after 15 minutes, a second text message will be sent out, again requesting a response. Satisfaction surveys will occur in the intervention group at week 5 when the text messages end; and will take five minutes.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER
  • Sparrow Health System

    collaborator OTHER
  • Diplomat Pharmacy

    collaborator UNKNOWN
  • Huron Medical Center

    collaborator OTHER
  • Allegiance Health

    collaborator OTHER
  • McLaren Cancer Institute

    collaborator UNKNOWN
  • Michigan State University

    lead OTHER

Principal Investigators

  • Sandra L Spoelstra, PhD, RN · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889511 on ClinicalTrials.gov