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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140252
• Other study ID #: UMCC 2021.087
• Secondary ID: HUM00195321
• Status: Completed
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: September 14, 2023

Study information

• Verified date: December 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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