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Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making

Primary Purpose

Breast Cancer, Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web-based decision aid
Standard websites
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers
  1. >18 years of age
  2. Newly diagnosed stage 0-3 breast cancer
  3. English speaking
  4. Has an email address
  5. No prior recent contact with the breast surgeon

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Web-based decision aid

    Standard websites

    Arm Description

    A commercially available web-based breast cancer surgery decision aid

    selected, high-quality standard web-sites

    Outcomes

    Primary Outcome Measures

    Knowledge using the Breast Cancer Decision Quality Instrument

    Secondary Outcome Measures

    Decisional concordance using the Breast Cancer Decision Quality Instrument
    Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
    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

    Full Information

    First Posted
    April 3, 2017
    Last Updated
    June 8, 2023
    Sponsor
    University of Wisconsin, Madison
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03116035
    Brief Title
    Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
    Official Title
    A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 24, 2014 (Actual)
    Primary Completion Date
    June 28, 2016 (Actual)
    Study Completion Date
    June 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Knowledge, Attitudes, Practice

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    244 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Web-based decision aid
    Arm Type
    Active Comparator
    Arm Description
    A commercially available web-based breast cancer surgery decision aid
    Arm Title
    Standard websites
    Arm Type
    Active Comparator
    Arm Description
    selected, high-quality standard web-sites
    Intervention Type
    Other
    Intervention Name(s)
    Web-based decision aid
    Intervention Description
    Patients were randomized to receive links to a commercially available decision aid.
    Intervention Type
    Other
    Intervention Name(s)
    Standard websites
    Intervention Description
    Patients were randomized to receive links to standard, high-quality websites.
    Primary Outcome Measure Information:
    Title
    Knowledge using the Breast Cancer Decision Quality Instrument
    Time Frame
    immediately prior to the surgical consultation
    Secondary Outcome Measure Information:
    Title
    Decisional concordance using the Breast Cancer Decision Quality Instrument
    Time Frame
    immediately prior to the surgical consultation
    Title
    Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
    Time Frame
    following the surgical consultation but prior to the surgery
    Title
    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
    Time Frame
    at completion of patient accrual, estimated to be 2 years after initiating study

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29246705
    Citation
    Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12.
    Results Reference
    derived

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