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

NCT05140252 | Completed

• 2 other identifiers: UMCC 2021.087HUM00195321
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

de-implementation strategies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Satisfaction with decision (SWD)

  up to 120-days following surgery

• Treatment choice

  90 days after surgery

Study Arms (1)

Breast cancer decision aid

EXPERIMENTAL

Participants receive a breast cancer decision aid.

Behavioral: Breast cancer decision aid

Interventions

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.

Breast cancer decision aid

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Male patients (current data does not support omission of SLNB in men)

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related 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.

  PMID: 31130442 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lesly A Dossett, MD, MPH

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: May 12, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)