Implementation of a Web-based Decision Aid for Breast Cancer Surgery

NCT ID: NCT03304002

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-04

Study Completion Date

2020-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Routine incorporation of decision aids into oncology practice has the potential to significantly improve patients' experiences with cancer by increasing the likelihood that they make informed treatment decisions aligned with their values. Unfortunately, only a minority of the more than 1.6 million patients diagnosed annually with cancer ever receive one due to limited clinic resources for administration and challenges in timely identification of appropriate patients. Online delivery directly to patients addresses some of these barriers but is insufficient on its own to ensure accessibility for patients at the time they most benefit from support.19 It is critical that active, multi-faceted implementation strategies that target barriers to the widespread use of web-based decision aids be identified, as these tools have the potential to significantly improve the quality of oncologic care.

Based on strong preliminary work, the investigators have developed and piloted a package of implementation strategies that effectively overcomes barriers to delivery of a web-based breast cancer surgery decision aid in an academic and community clinic. Although the strategy was successful, patients were white and educated; further investigation is imperative in settings that provide care to underserved patients to ensure the intervention will mitigate, rather than worsen, existing disparities in breast cancer care. This is especially critical given that underserved patients may benefit most from shared decision-making interventions such as the one described. To study this, the investigators propose a pilot study within a clinic that serves a catchment area with a high proportion of African American, rural and low income patients. The investigators will iteratively assess and enhance our implementation package using concepts outlined in the Knowledge-to-Action Cycle, which emphasizes local context in balancing fidelity and flexibility. The specific aims are: 1) To identify patient and clinic level barriers to implementation of a web-based breast cancer surgery decision aid in a clinic that cares for underserved patients, and 2) To test and expand our current implementation package's ability to address barriers in a clinic that cares for underserved patients. The investigators will determine the reach of implementation and acceptability of this method of decision aid delivery to stakeholders.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breast Cancer Surgery Decision Aid

We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients newly diagnosed with Stage 0-3 breast cancer.

Exclusion Criteria

* None

Clinic Stakeholders:
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heather Neuman

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baptist Health System

Memphis, Tennessee, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A539740

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\SURGERY\GEN SURG

Identifier Type: OTHER

Identifier Source: secondary_id

5P30CA014520-43

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UW16147

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/15/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0588

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Breast Cancer Prevention Education
NCT01299623 COMPLETED NA