SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02524548|
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Medication Adherence||Other: SMS reminder||Not Applicable|
This study is a prospective randomised controlled parallel trial of SMS reminder versus standard care to investigate whether SMS reminder improves adherence to oral aromatase inhibitor (AI) therapy amongst women with breast cancer at 1-year follow-up.
All subjects will be randomised to receive either SMS reminder or standard care in a 1:1 ratio. Balanced permuted block randomisation will be implemented with random varying of block sizes of 4 or 6.
The sample size is estimated based on the primary endpoint of medication adherence (as measured via SMAQ) at 1-year. Assuming that the proportion of medication adherence in the intervention and control groups are 80% and 60% respectively, then based on a 5% significance level and a power of 90%, a minimum sample of 240 subjects (i.e. 120 per group) will be required. Further assuming an attrition rate of 10%, the anticipated trial size is 280 overall.
The assessment of medication adherence at 1-year (as measured via SMAQ) between the SMS reminder and control groups will be made using chi-square test. Adjustment for baseline covariate and potential confounders will be made using the logistic regression where appropriate.
Other measures of adherence such as the 1-year MPR, PDC and pill count will be compared between treatment arms via the t- test, with adjustment for confounders made via the analysis of covariance (ANCOVA).
Natural log transformation will be implemented on the estrone and androstenedione measures to normalise the data. The assessment of secondary outcomes involving the log transformed estrone and androstenedione levels will be made using the analysis of covariance (ANCOVA) to adjust for the respective baseline levels and other potential confounders. Comparison of estradiol levels (defined as <18.4 versus ≥18.4) between the two arms will be made using chi-square test. The logistic regression analysis will be implemented to adjust for baseline covariate and other potential confounders where appropriate.
The assessment of knowledge, attitude, behavior, as well as barrier and facilitating factors between the intervention and control groups will be made using chi-square test, with treatment effect quantified based on odds ratio estimate and its 95% CI. Further adjustment for baseline scores and other potential confounders will be made using the logistic regression where appropriate.
Additionally, the investigators will compare the 4 different measures of adherence in a separate paper, to determine which of these provide a more meaningful or reliable information in the local context based on sensitivity analysis.
All analyses will be performed according to intention-to-treat using STATA, assuming a two-sided test at the 5% level of significance.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Improving Medication Adherence With Adjuvant Aromatase Inhibitor in Women With Breast Cancer: A Randomised Controlled Trial to Evaluate the Effect of Short Message Service (SMS) Reminder|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||January 2020|
Experimental: SMS reminder
Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor
Other: SMS reminder
Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor for 1 year
No Intervention: Standard care
- Medication adherence [ Time Frame: One year ]Simplified medication adherence questionnaire (SMAQ)
- Androstenedione [ Time Frame: One year ]in nmol/L
- Estrone [ Time Frame: One year ]in pg/mL
- Estradiol [ Time Frame: One year ]in pmol/L
- Patients' knowledge, attitude, and behavior towards medication adherence [ Time Frame: One year ]The Beliefs about Medicines Questionnaire (BMQ)
- Patients' knowledge, attitude, and behavior towards medication adherence [ Time Frame: One year ]Adherence Starts with Knowledge (ASK)-12 survey
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): NCT02524548
|National University Hospital|
|Singapore, Singapore, 119628|
|Ng Teng Fong General Hospital|
|Singapore, Singapore, 609606|
|Principal Investigator:||Bee Choo Tai, PhD||National University, Singapore|