Brief Summary

This trial studies the effectiveness of two interventions on patient reported outcomes of patient centered communication and decision making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns.

Trial Health

On Track

Trial Health Score

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

Enrollment

543

participants targeted

Target at P75+ for not_applicable

Timeline

8mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach

1 country

27 active sites

Status

active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

5.9 years study duration

Study Progress89%

Feb 2021Jan 2027

First Submitted

Initial submission to the registry

September 9, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed

2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

September 9, 2020

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

Patient knowledge about risks and benefits of local regional treatment
Will be defined as the percentage of correct answers (range: 0-100%) from a 5-item scale previously developed and pilot tested where higher percentages indicate increased knowledge of treatment risks and benefits of local regional treatment. Because the interventions are fully crossed (with intervention and control patients within both intervention and control practices for every time period), the intervention effect of iCanDecide-E and the intervention effect of the clinician dashboard (CDB) will be obtained from a single linear mixed-effects model for the continuous primary outcome measure patient knowledge.
At 4-5 weeks post patient randomization

Secondary Outcomes (2)

Patient self-efficacy in dealing with breast cancer
At 4-5 weeks post patient randomization
Patient cancer worry
At 4-5 weeks post patient randomization

Study Arms (9)

Arm I: (iCanDecide - ESE)

EXPERIMENTAL

Patients utilize the iCanDecide - ESE website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

Other: Decision Aid iCanDecide - ESE websiteProcedure: Therapeutic Conventional SurgeryOther: InterviewOther: Survey AdministrationOther: Quality-of-Life Assessment

Arm II: (iCanDecide - S)

ACTIVE COMPARATOR

Patients utilize the iCanDecide - S website, then undergo surgery within 5 weeks of registration. Patients may also participate in an audio-recorded phone interview over 20 minutes at 9-12 months post registration.

Other: Decision Aid iCanDecide - S websiteProcedure: Therapeutic Conventional SurgeryOther: InterviewOther: Survey AdministrationOther: Quality-of-Life Assessment

Clinics 1-5: (CDB)

EXPERIMENTAL

Beginning 4 weeks before the practice begins use of the CDB, clinicians receive training on how to use the CDB and utilize the CDB over weeks 1-60. Clinicians may also participate in an audio-recorded phone interview over 20 minutes.