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Completed

NCT Number: NCT05140252

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Acceptability of Intervention (AIM) Survey

    Time frame: 1 week after receiving decision aid

    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.

  2. Intervention Appropriateness Measure (IAM)

    Time frame: 1 week after receiving decision aid

    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.

  3. Engagement with the patient decision aid

    Time frame: 1 week after receiving 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 outcomes

  1. Satisfaction with decision (SWD)

    Time frame: up to 120-days following surgery

    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.

  2. Treatment choice

    Time frame: 90 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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