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Text Messaging to Improve Adherence to Oral Chemotherapy Agents

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ClinicalTrials.gov Identifier: NCT01889511
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : September 21, 2015
Sponsor:
Collaborators:
Yale University
Sparrow Health System
Diplomat Pharmacy
Huron Medical Center
Allegiance Health
McLaren Cancer Institute
Information provided by (Responsible Party):
Sandra Spoelstra, Michigan State University

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Intervention group - texts Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Text Messaging to Improve Adherence to Oral Chemotherapy Agents
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Intervention group - texts
The intervention group will receive text messages for 21 days that are tailored to their oral agent regimen.
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.

No Intervention: Control group
The 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.



Primary Outcome Measures :
  1. Feasibility, defined as patient acceptance of a text message intervention among patients who are on oral agents. [ Time Frame: Baseline to week-10. ]
    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.

  2. Feasibility, defined as retention in the study, among patients who are on oral agents. [ Time Frame: Baseline. ]
    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.

  3. Feasibility defined as satisfaction with a text message intervention among patients who are on oral agents. [ Time Frame: At week-4 after completion of text messages. ]
    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%.


Secondary Outcome Measures :
  1. Preliminary efficacy of the text message intervention on adherence to oral agents. [ Time Frame: Calculated weekly from baseline to week 10; cumulative for the 10-week study period; and then intervention and control group are compared.. ]
    Patients will be asked to recall and report the number pills taken (pill count) in the past 7 days at exit.

  2. Preliminary efficacy of the text message intervention on adherence to oral agents. [ Time Frame: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared. ]
    The proportion of oral agent pills taken compared to what was prescribed will be calculated to determine the rate of adherence. Adherence will be examined at 3 levels: under-adherent (taking less than 85% of the prescribed dose); over-adherent (taking more than 100% of the prescribed dose in AM, PM, or both, or taking during rest periods); and adherent (taking between 85% and 100% of the medication); and cumulative.

  3. Preliminary efficacy of the text message intervention on adherence to oral agents. [ Time Frame: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared.. ]
    The relative dose intensity (RDI) will be calculated by examining the dose taken divided by standard dose intensity (prescribed number of pills) x 100.


Other Outcome Measures:
  1. The effects of oral agent complexity, self-efficacy, symptom severity, and comorbid conditions on the intervention on adherence to oral agents. [ Time Frame: Baseline and at 10 weeks in the study. ]
    The Cancer Self-Efficacy Scale (CASE), a self-report measure, will be administered (internal consistency reliability 0.95); Symptom Experience Inventory; and comorbidity presence on adherence as in stated measures



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Deaf, blind, or unable hear, or unable to accept phone calls
  • Prescribed hormonal therapy for cancer treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889511


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520-8034
United States, Michigan
Diplomat Specialty Pharmacy
Flint, Michigan, United States, 48507
McLaren Cancer Institute
Flint, Michigan, United States, 48532
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Huron Medical Center
Port Huron, Michigan, United States, 48060
Sponsors and Collaborators
Michigan State University
Yale University
Sparrow Health System
Diplomat Pharmacy
Huron Medical Center
Allegiance Health
McLaren Cancer Institute
Investigators
Principal Investigator: Sandra L Spoelstra, PhD, RN Michigan State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandra Spoelstra, Assistant Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT01889511     History of Changes
Other Study ID Numbers: 1R15CA176595 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by Sandra Spoelstra, Michigan State University:
Text Messaging
Medication Adherence
Oral Agents