NCT02488603

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable breast-cancer

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

July 2, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

June 25, 2015

Last Update Submit

July 1, 2015

Conditions

Breast Cancer

Keywords

Breast NeoplasmsTamoxifenDecision Aids

Outcome Measures

Primary Outcomes (1)

  • Change in Knowledge of Tamoxifen Scale

    baseline, 4weeks later

Secondary Outcomes (4)

  • Decisional Conflict Scale

    baseline, 4weeks later

  • Satisfaction with Decision Questionnaire

    baseline, 4weeks later

  • EORTC QLQ-C30 Questionnaire

    baseline, 4weeks later

  • EQ-5D Questionnaire

    baseline, 4weeks later

Study Arms (2)

Decision aids

EXPERIMENTAL
Behavioral: Decision aids (tamoxifen-related educational materials in brochure or mobile app)Drug: tamoxifen

usual care

NO INTERVENTION

Interventions

Decision aids (tamoxifen-related educational materials in brochure or mobile app)BEHAVIORAL

Decision aids (tamoxifen-related educational materials in brochure or mobile app)

Decision aids
tamoxifenDRUG
Decision aids

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support TechniquesTamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 2, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2018

Last Updated

July 2, 2015

Record last verified: 2015-06