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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03304002
Enrollment
11
Registered
2017-10-06
Start date
2019-04-04
Completion date
2020-05-12
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Surgery

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.

Interventions

OTHERBreast Cancer Surgery Decision Aid

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reach: Proportion of Participants who Utilize the Decision Aidmeasured over the 4 month implementation periodReach 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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026