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SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors

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ClinicalTrials.gov Identifier: NCT02524548
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
National University Cancer Institute, Singapore
Singapore Cancer Society
Information provided by (Responsible Party):
Bee-Choo Tai, National University, Singapore

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Medication Adherence Other: SMS reminder Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Medication adherence [ Time Frame: One year ]
    Simplified medication adherence questionnaire (SMAQ)


Secondary Outcome Measures :
  1. Androstenedione [ Time Frame: One year ]
    in nmol/L

  2. Estrone [ Time Frame: One year ]
    in pg/mL

  3. Estradiol [ Time Frame: One year ]
    in pmol/L


Other Outcome Measures:
  1. Patients' knowledge, attitude, and behavior towards medication adherence [ Time Frame: One year ]
    The Beliefs about Medicines Questionnaire (BMQ)

  2. Patients' knowledge, attitude, and behavior towards medication adherence [ Time Frame: One year ]
    Adherence Starts with Knowledge (ASK)-12 survey


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT02524548


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119628
Ng Teng Fong General Hospital
Singapore, Singapore, 609606
Sponsors and Collaborators
National University, Singapore
National University Cancer Institute, Singapore
Singapore Cancer Society
Investigators
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Principal Investigator: Bee Choo Tai, PhD National University, Singapore
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bee-Choo Tai, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02524548    
Other Study ID Numbers: DSRB 2014/01316
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bee-Choo Tai, National University, Singapore:
Aromatase inhibitors
Reminder Systems
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases