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Clinical Trials/NCT03116035
NCT03116035CompletedNot Applicable

A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making

University of Wisconsin, Madison0 sites244 target enrollmentStarted: April 24, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
244
Primary Endpoint
Knowledge using the Breast Cancer Decision Quality Instrument
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •>18 years of age
  • •Newly diagnosed stage 0-3 breast cancer
  • •English speaking
  • •Has an email address
  • •No prior recent contact with the breast surgeon

Exclusion Criteria

  • Not provided

Arms & Interventions

Web-based decision aid

Active Comparator

A commercially available web-based breast cancer surgery decision aid

Intervention: Web-based decision aid (Other)

Standard websites

Active Comparator

selected, high-quality standard web-sites

Intervention: Standard websites (Other)

Outcomes

Primary Outcomes

Knowledge using the Breast Cancer Decision Quality Instrument

Time Frame: immediately prior to the surgical consultation

Secondary Outcomes

  • Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument(following the surgical consultation but prior to the surgery)
  • Decisional concordance using the Breast Cancer Decision Quality Instrument(immediately prior to the surgical consultation)
  • Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey(at completion of patient accrual, estimated to be 2 years after initiating study)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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