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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Breast cancer decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast cancer decision aid; Participants receive a breast cancer decision aid.	Behavioral: Breast 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Lesly A Dossett, MD, MPH, University of Michigan Rogel Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: de-implementation strategies
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UMCC 2021.087; HUM00195321 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No