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

Breast Cancer Clinical Trial

Official title:

Implementation of a Web-based Decision Aid for Breast Cancer Surgery: Adapting to the Needs of Diverse Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304002
• Other study ID #: 2017-0588
• Secondary ID: A539740SMPH\SURG
• Status: Completed
• Start date: April 4, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: May 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Patients:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Other:
• Breast Cancer Surgery Decision Aid
We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation

Locations

Country	Name	City	State
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Baptist Health System	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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