Breast Cancer
Conditions
Keywords
de-implementation strategies
Brief summary
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
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.
Interventions
BEHAVIORALBreast cancer decision aid
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.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention (AIM) Survey | 1 week after receiving decision aid | 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. |
| Intervention Appropriateness Measure (IAM) | 1 week after receiving decision aid | 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. |
| Engagement with the patient decision aid | 1 week after receiving 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with decision (SWD) | up to 120-days following surgery | 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. |
| Treatment choice | 90 days after surgery | 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. |
Countries
United States
Outcome results
None listed