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

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: Breast Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Informational Intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Hertz; Phone Number: 734-763-0015; Email: DLHertz@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Comprehensive Cancer Center
      • Contact: Daniel L. Hertz; Phone Number: 734-763-0015; Email: DLHertz@med.umich.edu
      • Principal Investigator: Daniel L. Hertz

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.	up to 12 weeks
Change in discussion confidence	Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.	up to 12 weeks
Change in decision preparedness	Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.	up to 12 weeks
Change in decision empowerment	Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.	up to 12 weeks
Discussion satisfaction	Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.	up to 12 weeks
Decision satisfaction	Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.	up to 12 weeks
Helpfulness	Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.	up to 12 weeks
Taxane chemotherapy treatment decision	Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.	up to 12 weeks

Collaborators and Investigators

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

Study record dates

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