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Decision Aids for Tamoxifen Treatment in Breast Cancer Patients

NCT ID: NCT02488603

Last Updated: 2015-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Decision aids

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

tamoxifen

Intervention Type DRUG

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type BEHAVIORAL

tamoxifen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eun Sook Lee

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NCCKorea

Identifier Type: -

Identifier Source: org_study_id

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