- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02488603
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
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
|
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
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
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
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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