N/A N=322 Randomized Double-blind Supportive Care

Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)

Ductal Carcinoma in Situ

Bottom Line

View on ClinicalTrials.gov: NCT03775213 ↗

Enrolled (actual)

322

Serious AEs

—

Results posted

Jan 2023

Primary outcome: Primary: Number of Participants Who Chose Active Monitoring (AM). — 28; 18 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Decision Support Tool with Active Monitoring (Behavioral); Decision Support Tool without Active Monitoring (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Chose Active Monitoring (AM).	28; 18	—
SECONDARY Number of Participants Who Found the Treatment Option Acceptable.	32; 32; 50; 47; 34; 38	—
SECONDARY Number of Participants Who Perceived Active Monitoring as Risky.	18; 17	—
SECONDARY Number of Participants Who Chose Mastectomy.	14; 15	—
SECONDARY Change in Self-perceived Knowledge About DCIS.	2; 2.5	—

Summary

The purpose of this research study is to evaluate a decision support tool for patients diagnosed with ductal carcinoma in situ (DCIS).

Eligibility Criteria

Inclusion Criteria

Sex: Female
Age: 50-79 years
Has had a negative mammographic screen in the past 12 months

Exclusion Criteria

Personal history of breast cancer

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Data sourced from ClinicalTrials.gov (NCT03775213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.