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

NCT03304002 | Completed

• 6 other identifiers: 2017-0588A539740SMPH\SURGERY\GEN SURG5P30CA014520-43UW16147Protocol Version 3/15/2019
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer; Surgery

Outcome Measures

Primary Outcomes (1)

• Reach: Proportion of Participants who Utilize the Decision Aid

  Reach of the implementation is defined as the proportion of participants over the four month implementation period who: 1) are sent the decision aid and 2) access the decision aid.

  measured over the 4 month implementation period

Secondary Outcomes (2)

• Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email

  Survey sent within 4 weeks of surgical consultation

• Barriers and Facilitators to Implementation of the Decision Aid

  Interviewed completed within 6 months of the surgical consultation

Interventions

Breast Cancer Surgery Decision Aid OTHER

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a clinic-level intervention with two stakeholder groups: (1) clinical staff, clinic leadership, and surgeons involved in implementation, and (2) patients newly diagnosed with Stage 0-3 breast cancer.

You may qualify if:

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

You may not qualify if:

• None
• Clinic Stakeholders:

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Baptist Health System

Memphis, Tennessee, 38120, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Heather Neuman

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 6, 2017
• Study Start: April 4, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

US (2)