Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid

Study Overview
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Brief Summary
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The aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.

Detailed Description
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This study seeks to adapt and pilot test de-implementation strategies targeting low-value breast cancer treatments which have persisted despite national recommendations. Breast cancer is an ideal setting in which to study de-implementation given it is common, well-studied, typically presents at an early-stage, and care is provided primarily in a community setting.

Official Title
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Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Breast cancer decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Early stage breast cancer that is hormone receptor positive (HR+) and human epidermal growth factor negative (HER2-) Meet criteria for omission of sentinel lymph node biopsy (SLNB) Receiving care at Michigan Medicine Exclusion Criteria Non-English speaking Male patients (current data does not support omission of SLNB in men)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast cancer decision aid<br>Participants receive a breast cancer decision aid. | Behavioral: Breast cancer decision aid<br>* The decision aid is tailored from a previously published aid, specific to women ≥70 with early-stage breast cancer. The aid will be delivered via mail or electronically per patient preference before the patient's initial appointment with a surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention (AIM) Survey | AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | 1 week after receiving decision aid | 
| Intervention Appropriateness Measure (IAM) | IAM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | 1 week after receiving decision aid | 
| Engagement with the patient decision aid | To determine feasibility, participants will be asked whether they engaged with the patient decision aid (1=thoroughly, 2=somewhat or 3=not at all), scored as a mean. The median score across all participants will be reported. | 1 week after receiving decision aid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with decision (SWD) | The SWD survey will be administered by telephone between 60- and 120-days following surgery. SWD is a validated, 6-item survey with all items measured on a 5-point Likert scale (Completely Disagree [1] - Completely Agree [5]), scored as a mean. The median score across all participants will be reported. | up to 120-days following surgery | 
| Treatment choice | The research team will access participants electronic medical records to determine the number of participants who underwent SLNB, radiation treatment, both or neither after surgery. This will be reported in 4 categories: Only SLNB, Only Radiation, Both or Neither. | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de-implementation strategies