NCT06915168 CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer
| NCT ID | NCT06915168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Daniel L Hertz
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT06915168 clinical trial?
This trial is open to participants of all sexes, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06915168 currently recruiting?
Yes, NCT06915168 is actively recruiting participants. Contact the research team at DLHertz@med.umich.edu for enrollment information.
Where is the NCT06915168 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06915168 clinical trial?
NCT06915168 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Daniel L Hertz at University of Michigan Rogel Cancer Center. The trial plans to enroll 20 participants.