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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT06915168
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-13
• Study First Submitted: 2025-03-11
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in decision preparedness	up to 12 weeks	Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States