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

University of Michigan Rogel Cancer Center

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Other: Survey Administration; Other: Informational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06915168

NCI-2024-10529 (Registry Identifier)

HUM00261498 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Supportive care (CIPN DecisionAid)

Experimental group

Description:

Patients receive the CIPN DecisionAid on study.

Treatment:

Other: Informational Intervention

Other: Survey Administration