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

Last updated: April 3, 2025
Sponsor: University of Michigan Rogel Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Carcinoma

Treatment

Survey Administration

Informational Intervention

Clinical Study ID

NCT06915168
HUM00261498
HUM00261498
NCI-2024-10529
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 itsworst? None, Mild, Moderate, Severe, Very Severe. Patient is eligible if theiranswer is anything except "None"

  • Access to a smartphone or similar device that can complete CIPN DecisionAid viaQualtrics while in the waiting room

Exclusion

Exclusion Criteria:

  • Inability to read or speak English

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Survey Administration
Phase:
Study Start date:
November 13, 2024
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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