SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors

June 25, 2020 updated by: Bee-Choo Tai, National University, Singapore

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

The purpose of this study is to determine whether weekly SMS reminders are effective in improving medication adherence of adjuvant aromatase inhibitors in women with breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 609606
        • Ng Teng Fong General Hospital
      • Singapore, Singapore, 119628
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women who have been receiving adjuvant endocrine therapy for at least 1 year, and are continuing to receive adjuvant AI therapy for at least 1 more year.
  2. Have cellular phone that can receive text messages.
  3. Singaporean or permanent resident who is currently residing in Singapore.
  4. Able to give informed consent.

Exclusion Criteria:

1. Unable or not willing to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: One year
Simplified medication adherence questionnaire (SMAQ)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Androstenedione
Time Frame: One year
in nmol/L
One year
Estrone
Time Frame: One year
in pg/mL
One year
Estradiol
Time Frame: One year
in pmol/L
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' knowledge, attitude, and behavior towards medication adherence
Time Frame: One year
The Beliefs about Medicines Questionnaire (BMQ)
One year
Patients' knowledge, attitude, and behavior towards medication adherence
Time Frame: One year
Adherence Starts with Knowledge (ASK)-12 survey
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Collaborators

Singapore Cancer Society
National University Cancer Institute, Singapore

Investigators

  • Principal Investigator: Bee Choo Tai, PhD, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2015

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (ESTIMATE)

August 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB 2014/01316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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