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Trial record 1 of 1 for:    NCT02524548 | breast cancer
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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

Tracking Information
First Submitted Date  ICMJE August 11, 2015
First Posted Date  ICMJE August 17, 2015
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Medication adherence [ Time Frame: One year ]
Simplified medication adherence questionnaire (SMAQ)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • Androstenedione [ Time Frame: One year ]
    in nmol/L
  • Estrone [ Time Frame: One year ]
    in pg/mL
  • Estradiol [ Time Frame: One year ]
    in pmol/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 14, 2015)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Breast Cancer
  • Medication Adherence
Intervention  ICMJE Other: SMS reminder
Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor for 1 year
Study Arms  ICMJE
  • Experimental: SMS reminder
    Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor
    Intervention: Other: SMS reminder
  • No Intervention: Standard care
    Routine care
Publications * He Y, Tan EH, Wong ALA, Tan CC, Wong P, Lee SC, Tai BC. Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: study protocol of a randomised controlled trial to evaluate the effect of short message service (SMS) reminder. BMC Cancer. 2018 Jul 9;18(1):727. doi: 10.1186/s12885-018-4660-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2019)
244
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
280
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02524548
Other Study ID Numbers  ICMJE DSRB 2014/01316
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bee-Choo Tai, National University, Singapore
Study Sponsor  ICMJE National University, Singapore
Collaborators  ICMJE
  • National University Cancer Institute, Singapore
  • Singapore Cancer Society
Investigators  ICMJE
Principal Investigator: Bee Choo Tai, PhD National University, Singapore
PRS Account National University, Singapore
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP