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OpenTrials
Completed

NCT Number: NCT03304002

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Health System, Memphis, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Cancer Surgery Decision Aid

Other

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

Primary outcomes

  1. Reach: Proportion of Participants who Utilize the Decision Aid

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Barriers and Facilitators to Implementation of the Decision Aid

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2017
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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