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

Completed

• Conditions: Breast Cancer; Surgery

• Registration Number: NCT03304002
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Study Start: 2019-04-04
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• None

Clinic Stakeholders:

Inclusion Criteria: clinical staff, clinic leadership, and surgeons involved in implementation Exclusion Criteria: none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reach: Proportion of Participants who Utilize the Decision Aid	measured over the 4 month implementation period	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.

Secondary Outcome Measures

Name	Time	Method
Barriers and Facilitators to Implementation of the Decision Aid	Interviewed completed within 6 months of the surgical consultation	One-on-one interviews with participants to identify those who experienced barriers and facilitators to implementing the decision aid
Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email	Survey sent within 4 weeks of surgical consultation	acceptability will be defined as \>80% of patients reporting they would recommend receiving breast cancer information via email to others.

Trial Locations

Locations (2)

Baptist Health System; 🇺🇸 Memphis, Tennessee, United States

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States