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CompletedNCT03304002Updated May 25, 2021

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

An observational study in Breast Cancer and Surgery, sponsored by University of Wisconsin, Madison. Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-05-25.

Sponsored by University of Wisconsin, Madison · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Surgery

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03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Patients:

Inclusion criteria

Inclusion Criteria:

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

Exclusion criteria

Exclusion Criteria:

  • None

Clinic Stakeholders:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Interventions

  • OtherBreast Cancer Surgery Decision Aid

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: measured over the 4 month implementation period

Secondary outcomes

  1. 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.

    Time frame: Survey sent within 4 weeks of surgical consultation

  2. 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

    Time frame: Interviewed completed within 6 months of the surgical consultation

06

Study locations

2 sites
  • Baptist Health System
    Memphis, Tennessee 38120, United States
  • University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin 53705, United States
07

Registry details

Key details

Study ID
NCT03304002
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Apr 4, 2019
Primary completion
May 12, 2020
Completion
May 12, 2020
Last update
May 25, 2021

Study contacts

Heather Neuman
principal investigator · University of Wisconsin, Madison

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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