CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer

April 7, 2026 updated by: University of Michigan Rogel Cancer Center

CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making

This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Daniel L. Hertz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with breast cancer
  • Currently receiving cycle three of taxane treatment
  • Approval of medical oncologist to enroll patient
  • Experiencing any CIPN based on enrollment screening question, "In the last 7 days, what was the severity of your numbness or tingling in your hands or feet at its worst? None, Mild, Moderate, Severe, Very Severe. Patient is eligible if their answer is anything except "None"
  • Access to a smartphone or similar device that can complete CIPN DecisionAid via Qualtrics while in the waiting room

Exclusion Criteria:

  • Inability to read or speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (CIPN DecisionAid)
Patients receive the CIPN DecisionAid on study.
Other: Survey Administration
Ancillary studies
Other: Informational Intervention
Given CIPN DecisionAid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in decision preparedness
Time Frame: up to 12 weeks
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in decision preparedness
Time Frame: up to 12 weeks
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey. A secondary analysis will be conducted using linear regression adjusting for the treatment (adjuvant versus [vs]. metastatic, paclitaxel vs. docetaxel, weekly vs. 3-weekly) and other baseline variables (e.g., age, chemotherapy-induced peripheral neuropathy [CIPN] severity).
up to 12 weeks
Change in awareness
Time Frame: up to 12 weeks
Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.
up to 12 weeks
Change in discussion confidence
Time Frame: up to 12 weeks
Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.
up to 12 weeks
Change in decision preparedness
Time Frame: up to 12 weeks
Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.
up to 12 weeks
Change in decision empowerment
Time Frame: up to 12 weeks
Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.
up to 12 weeks
Discussion satisfaction
Time Frame: up to 12 weeks
Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.
up to 12 weeks
Decision satisfaction
Time Frame: up to 12 weeks
Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.
up to 12 weeks
Helpfulness
Time Frame: up to 12 weeks
Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.
up to 12 weeks
Taxane chemotherapy treatment decision
Time Frame: up to 12 weeks
Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Daniel L Hertz, University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00261498 (Other Identifier: University of Michigan Comprehensive Cancer Center)
  • NCI-2024-10529 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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