Decision Aids for Tamoxifen Treatment in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02488603
• Other study ID #: NCCKorea
• Status: Not yet recruiting
• Phase: N/A
• First received: June 25, 2015
• Last updated: July 1, 2015
• Start date: August 2015

Study information

• Verified date: June 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: National Cancer Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Drug:
• tamoxifen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge of Tamoxifen Scale		baseline, 4weeks later	No
Secondary	Decisional Conflict Scale	Assess the decisional conflict regarding tamoxifen treatment	baseline, 4weeks later	No
Secondary	Satisfaction with Decision Questionnaire	Assess the satisfaction with decision to undergo tamoxifen treatment	baseline, 4weeks later	No
Secondary	EORTC QLQ-C30 Questionnaire	Assess the quality of life before and during tamoxfen treatment	baseline, 4weeks later	No
Secondary	EQ-5D Questionnaire	Assess the quality of life before and during tamoxfen treatment	baseline, 4weeks later	No