Breast Cancer
Conditions
Keywords
Breast Neoplasms, Tamoxifen, Decision Aids
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.
Interventions
BEHAVIORALDecision aids (tamoxifen-related educational materials in brochure or mobile app)
Decision aids (tamoxifen-related educational materials in brochure or mobile app)
DRUGtamoxifen
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Knowledge of Tamoxifen Scale | baseline, 4weeks later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | baseline, 4weeks later | Assess the decisional conflict regarding tamoxifen treatment |
| Satisfaction with Decision Questionnaire | baseline, 4weeks later | Assess the satisfaction with decision to undergo tamoxifen treatment |
| EORTC QLQ-C30 Questionnaire | baseline, 4weeks later | Assess the quality of life before and during tamoxfen treatment |
| EQ-5D Questionnaire | baseline, 4weeks later | Assess the quality of life before and during tamoxfen treatment |
Outcome results
None listed