Back to resultsAvoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast cancer decision aid
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring de-implementation strategies
Eligibility Criteria
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)
Sites / Locations
- University of Michigan Rogel Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast cancer decision aid
Arm Description
Participants receive a breast cancer decision aid.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05140252
First Posted
November 17, 2021
Last Updated
September 11, 2023
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05140252
Brief Title
Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
Official Title
Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
de-implementation strategies
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer decision aid
Arm Type
Experimental
Arm Description
Participants receive a breast cancer decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Breast cancer decision aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention (AIM) Survey
Description
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.
Time Frame
1 week after receiving decision aid
Title
Intervention Appropriateness Measure (IAM)
Description
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.
Time Frame
1 week after receiving decision aid
Title
Engagement with the patient decision aid
Description
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.
Time Frame
1 week after receiving decision aid
Secondary Outcome Measure Information:
Title
Satisfaction with decision (SWD)
Description
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.
Time Frame
up to 120-days following surgery
Title
Treatment choice
Description
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.
Time Frame
90 days after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesly A Dossett, MD, MPH
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31130442
Citation
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.
Results Reference
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Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
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