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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06915168
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Informational Intervention — OTHER
    Given CIPN DecisionAid
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (CIPN DecisionAid)
    Patients receive the CIPN DecisionAid on study.

Primary Outcome Measure

Change in decision preparedness [ Time Frame: up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Daniel L. Hertz
734-763-0015
Daniel L. Hertz (PRINCIPAL_INVESTIGATOR)

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