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
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Intervention group - texts||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|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|
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.
- 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.
- 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.
- 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%.
- 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.
- 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.
- 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.
- 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
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
|United States, Connecticut|
|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|
|Jackson, Michigan, United States, 49201|
|Lansing, Michigan, United States, 48912|
|Huron Medical Center|
|Port Huron, Michigan, United States, 48060|
|Principal Investigator:||Sandra L Spoelstra, PhD, RN||Michigan State University|