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

NCT03116035 | Completed

• 2 other identifiers: 2013-1500UW13089
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

• Knowledge using the Breast Cancer Decision Quality Instrument

  immediately prior to the surgical consultation

Secondary Outcomes (3)

• Decisional concordance using the Breast Cancer Decision Quality Instrument

  immediately prior to the surgical consultation

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

  following the surgical consultation but prior to the surgery

• 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

Study Arms (2)

Web-based decision aid

ACTIVE COMPARATOR

A commercially available web-based breast cancer surgery decision aid

Other: Web-based decision aid

Standard websites

ACTIVE COMPARATOR

selected, high-quality standard web-sites

Other: Standard websites

Interventions

Web-based decision aid OTHER

Patients were randomized to receive links to a commercially available decision aid.

Web-based decision aid

Standard websites OTHER

Patients were randomized to receive links to standard, high-quality websites.

Standard websites

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Related Publications (1)

• 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.

  PMID: 29246705 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 14, 2017
• Study Start: April 24, 2014
• Primary Completion: June 28, 2016
• Study Completion: June 28, 2016
• Last Updated: June 12, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share