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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00195321 | Other Identifier | University of Michigan |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer decision aid | Experimental | Participants receive a breast cancer decision aid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast cancer decision aid | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lesly A Dossett, MD, MPH | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31130442 | Background | Schonberg MA, Freedman RA, Recht AR, Jacobson AR, Aliberti GM, Karamourtopoulos M, Nakhlis F, McCarthy EP, Pories SE, Sharma R, Dominici LS. Developing a patient decision aid for women aged 70 and older with early stage, estrogen receptor positive, HER2 negative, breast cancer. J Geriatr Oncol. 2019 Nov;10(6):980-986. doi: 10.1016/j.jgo.2019.05.004. Epub 2019 May 24. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |