NCT03775213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
2.8 years until next milestone

Study Start

First participant enrolled

October 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

December 11, 2018

Results QC Date

December 2, 2022

Last Update Submit

January 4, 2023

Conditions

Ductal Carcinoma in Situ

Keywords

Ductal carcinoma in situDecision support toolInformed decision-makingOvertreatmentActive surveillanceActive monitoring

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Chose Active Monitoring (AM).

    Presented to participants as a categorical item: active monitoring (AM), lumpectomy, lumpectomy with radiation, mastectomy. Recorded for analysis as binary: AM vs non-AM.

    Up to 1 hour

Secondary Outcomes (4)

  • Number of Participants Who Found the Treatment Option Acceptable.

    Up to 1 hour

  • Number of Participants Who Perceived Active Monitoring as Risky.

    Up to 1 hour

  • Number of Participants Who Chose Mastectomy.

    Up to 1 hour

  • Change in Self-perceived Knowledge About DCIS.

    Baseline and 1 hour

Other Outcomes (16)

  • Self-reported Breast Cancer Knowledge

    Up to 1 hour

  • Treatment Choice Reason

    Up to 1 hour

  • Choice Confidence (Chambers et al., 2012)

    Up to 1 hour

  • +13 more other outcomes

Study Arms (2)

Standard Treatment Options + Active Monitoring

EXPERIMENTAL

Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.

Behavioral: Decision Support Tool with Active Monitoring

Standard Treatment Options

ACTIVE COMPARATOR

Participants explore decision support tool that includes current standard treatment options for DCIS.

Behavioral: Decision Support Tool without Active Monitoring

Interventions

Decision Support Tool with Active MonitoringBEHAVIORAL

The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.

Standard Treatment Options + Active Monitoring
Decision Support Tool without Active MonitoringBEHAVIORAL

The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.

Standard Treatment Options

Eligibility Criteria

Age50 Years - 79 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Personal history of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Mammography Clinic

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

Title
Dr. Marc D. Ryser
Organization
Duke University
marc.ryser@duke.edu
(919) 684 8294

Study Officials

  • Marc D Ryser, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

October 12, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

January 30, 2023

Results First Posted

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)