Text Messaging to Improve Adherence to Oral Chemotherapy Agents
1 other identifier
interventional
75
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jun 2013
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 21, 2015
September 1, 2015
1.5 years
June 24, 2013
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility, defined as patient acceptance of a text message intervention among patients who are on oral agents.
Feasibility of adherence to tailored text messages will be measured by the number of text messages delivered and any discontinuation of text messages during the course of the study while treatment with the oral agent is ongoing.
Baseline to week-10.
Feasibility, defined as retention in the study, among patients who are on oral agents.
Acceptability of tailored text messaging will be measured by the number of patients who accept enrollment in the study compared to the number of patients who were offered to participate and by the percent of patients who complete the study. Acceptability will be assessed qualitatively by examining the reasons for attrition in the intervention group.
Baseline.
Feasibility defined as satisfaction with a text message intervention among patients who are on oral agents.
Satisfaction with tailored text messages for adherence will be measured using a tool previously developed by this research team and administered in several previous studies that had Likert-scaled items. These Likert-scaled items will be modified for this study, adding items describing dimensions of satisfaction with the text messages. Satisfaction will be deemed high if the scores exceed 80%.
At week-4 after completion of text messages.
Secondary Outcomes (3)
Preliminary efficacy of the text message intervention on adherence to oral agents.
Calculated weekly from baseline to week 10; cumulative for the 10-week study period; and then intervention and control group are compared..
Preliminary efficacy of the text message intervention on adherence to oral agents.
Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared.
Preliminary efficacy of the text message intervention on adherence to oral agents.
Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared..
Other Outcomes (1)
The effects of oral agent complexity, self-efficacy, symptom severity, and comorbid conditions on the intervention on adherence to oral agents.
Baseline and at 10 weeks in the study.
Study Arms (2)
Intervention group - texts
EXPERIMENTALThe intervention group will receive text messages for 21 days that are tailored to their oral agent regimen.
Control group
NO INTERVENTIONThe control group will receive usual care, which consists of standard care and materials provided by the oncology office or pharmacy. In general, this includes instructions and information on the oral agent regimen (i.e., amount and timing), common side effects, how to manage symptoms, general ways to remember to take your pill (e.g., calendar or pill box), medication safety (i.e., storage), and how to contact a clinician for problems that arise.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with cancer
- Prescribed an oncolytic or therapeutic oral agent (non-hormonal)
- Able to speak, read, and understand English
- Able and willing to receive phone calls
- Has a personal cell phone, and able and willing to receive and send a text message
You may not qualify if:
- Deaf, blind, or unable hear, or unable to accept phone calls
- Prescribed hormonal therapy for cancer treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michigan State Universitylead
- Yale Universitycollaborator
- Sparrow Health Systemcollaborator
- Diplomat Pharmacycollaborator
- Huron Medical Centercollaborator
- Allegiance Healthcollaborator
- McLaren Cancer Institutecollaborator
Study Sites (6)
Yale University
New Haven, Connecticut, 06520-8034, United States
Diplomat Specialty Pharmacy
Flint, Michigan, 48507, United States
McLaren Cancer Institute
Flint, Michigan, 48532, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Huron Medical Center
Port Huron, Michigan, 48060, United States
Related Publications (1)
Spoelstra SL, Given CW, Sikorskii A, Coursaris CK, Majumder A, DeKoekkoek T, Schueller M, Given BA. 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.
PMID: 26100719DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra L Spoelstra, PhD, RN
Michigan State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 24, 2013
First Posted
June 28, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
September 21, 2015
Record last verified: 2015-09