Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer

June 13, 2017 updated by: Yul Ha Min, Gachon University
A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Baseline measurement (n=200): screening and enrollment
  • 3-month visit: collecting MEMS data
  • 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
  • 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
  • 18-month visit: collecting MEMS data and interview

Study Type

Interventional

Enrollment (Anticipated)

200

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

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage 0-III breast cancer
  • Treated with Adjuvant hormonal therapy

Exclusion Criteria:

  • Stage IV breast cancer
  • Breast cancer recurrence or metastasis
  • Severe medical illness

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: high adherence control group
-Patients on continuous MEMS monitoring with usual care.
No Intervention: low adherence control group
-Patients on continuous MEMS monitoring with usual care.
Experimental: low adherence intervention group
  • Patient with the WALKON mobile application.
  • Patient with monthly feedback call
  • Patients on continuous MEMS monitoring.
Behavioral: low adherence intervention group
Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity (daily steps)
Time Frame: 12 months
Comparison of daily steps using WALKON application
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence using MEMS device
Time Frame: 18 months
Comparison of adjuvant hormonal therapy adherence using MEMS device
18 months

Collaborators and Investigators

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

Sponsor

Gachon University

Collaborators

Asan Medical Center

Investigators

  • Principal Investigator: Yul ha Min, PhD, Gachon University

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)

June 8, 2017

Primary Completion (Anticipated)

October 31, 2018

Study Completion (Anticipated)

October 31, 2018

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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