Clinical trial NCT03304002: Implementation of a Web-based Decision Aid for Breast Cancer Surgery
Official title: Implementation of a Web-based Decision Aid for Breast Cancer Surgery: Adapting to the Needs of Diverse Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Surgery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-10-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 Exclusion Criteria: none

Primary outcomes:
measure: Reach: Proportion of Participants who Utilize the Decision Aid
timeFrame: measured over the 4 month implementation period
Secondary outcomes:
measure: Acceptability: Percentage of Participants Who Would Recommend Receiving Breast Cancer Information Via Email
timeFrame: Survey sent within 4 weeks of surgical consultation
measure: Barriers and Facilitators to Implementation of the Decision Aid
timeFrame: Interviewed completed within 6 months of the surgical consultation
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Baptist Health System
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Heather Neuman
role: PRINCIPAL_INVESTIGATOR
References: