Decision Aids for Tamoxifen Treatment in Breast Cancer Patients

July 1, 2015 updated by: Eun Sook Lee, National Cancer Center, Korea

Utilization of Decision Aids for Tamoxifen Treatment in Breast Cancer Patients: A Randomized Controlled Trial.

This is an educational intervention study for breast cancer patients who undergo tamoxifen treatment. The purpose of the study is to assess the impact of decision aids (DA) on the patients' decision-making process, compliance on drug, and knowledge regarding tamoxifen treatment. Patients will randomly assign to DA group or conventional group. Both groups will have baseline questionnaire surveys before starting tamoxifen treatment, and 4 weeks later follow-up questionnaire surveys.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Breast cancer patients who are recommended to undergo tamoxifen treatment in National Cancer Center, Korea
  • - Age at least 18 years and more

Exclusion Criteria:

  • Age under 18 years
  • Inability to read or speak Korean
  • Disagree to provide a written informed consent

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Experimental: Decision aids
Drug: tamoxifen
Behavioral: Decision aids (tamoxifen-related educational materials in brochure or mobile app)
Decision aids (tamoxifen-related educational materials in brochure or mobile app)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Knowledge of Tamoxifen Scale
Time Frame: baseline, 4weeks later
baseline, 4weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale
Time Frame: baseline, 4weeks later
Assess the decisional conflict regarding tamoxifen treatment
baseline, 4weeks later
Satisfaction with Decision Questionnaire
Time Frame: baseline, 4weeks later
Assess the satisfaction with decision to undergo tamoxifen treatment
baseline, 4weeks later
EORTC QLQ-C30 Questionnaire
Time Frame: baseline, 4weeks later
Assess the quality of life before and during tamoxfen treatment
baseline, 4weeks later
EQ-5D Questionnaire
Time Frame: baseline, 4weeks later
Assess the quality of life before and during tamoxfen treatment
baseline, 4weeks later

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

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

August 1, 2015

Primary Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCKorea

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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