SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors

• ClinicalTrials.gov Identifier: NCT02524548
• Recruitment Status: Completed
• First Posted: August 17, 2015
• Last Update Posted: June 29, 2020
• Sponsor: National University, Singapore
• 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: August 11, 2015
• First Posted Date: August 17, 2015
• Last Update Posted Date: June 29, 2020
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2015)

Medication adherence [ Time Frame: One year ]

Simplified medication adherence questionnaire (SMAQ)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: 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: SMS Reminders to Improve Medication Adherence of Aromatase Inhibitors
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Breast Cancer
• Medication Adherence

Intervention

Other: SMS reminder

Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor for 1 year

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2019): 244
• Original Estimated Enrollment (submitted: August 14, 2015): 280
• Actual Study Completion Date: January 2020
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02524548
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Bee-Choo Tai, National University, Singapore
• Study Sponsor: National University, Singapore

Collaborators

• National University Cancer Institute, Singapore
• Singapore Cancer Society

Investigators

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

• PRS Account: National University, Singapore
• Verification Date: June 2020