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

G

Gachon University

Status

Unknown

Conditions

Breast Cancer

Treatments

Behavioral: low adherence intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT03186599
2016-0351

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 3 patient groups

high adherence control group
No Intervention group
Description:
-Patients on continuous MEMS monitoring with usual care.
low adherence control group
No Intervention group
Description:
-Patients on continuous MEMS monitoring with usual care.
low adherence intervention group
Experimental group
Description:
Patient with the WALKON mobile application. Patient with monthly feedback call Patients on continuous MEMS monitoring.
Treatment:
Behavioral: low adherence intervention group

Trial contacts and locations

0

Loading...

Central trial contact

Yul ha Min, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems