NCT02524548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

4.6 years

First QC Date

August 11, 2015

Last Update Submit

June 25, 2020

Conditions

Keywords

Aromatase inhibitorsReminder Systems

Outcome Measures

Primary Outcomes (1)

  • Medication adherence

    Simplified medication adherence questionnaire (SMAQ)

    One year

Secondary Outcomes (3)

  • Androstenedione

    One year

  • Estrone

    One year

  • Estradiol

    One year

Other Outcomes (2)

  • Patients' knowledge, attitude, and behavior towards medication adherence

    One year

  • Patients' knowledge, attitude, and behavior towards medication adherence

    One year

Study Arms (2)

SMS reminder

EXPERIMENTAL

Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor

Other: SMS reminder

Standard care

NO INTERVENTION

Routine care

Interventions

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

SMS reminder

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Have cellular phone that can receive text messages.
  • Singaporean or permanent resident who is currently residing in Singapore.
  • Able to give informed consent.

You may not qualify if:

  • \. Unable or not willing to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, 119628, Singapore

Location

Ng Teng Fong General Hospital

Singapore, 609606, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsMedication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bee Choo Tai, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 17, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations