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

NCT ID: NCT05140252

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-09-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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de-implementation strategies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Breast cancer decision aid

Participants receive a breast cancer decision aid.

Group Type EXPERIMENTAL

Breast cancer decision aid

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lesly A Dossett, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31130442 (View on PubMed)

Other Identifiers

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HUM00195321

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2021.087

Identifier Type: -

Identifier Source: org_study_id