Clinical trial NCT06915168: CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer
Official title: CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: Change in decision preparedness
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in decision preparedness
timeFrame: up to 12 weeks
measure: Change in awareness
timeFrame: up to 12 weeks
measure: Change in discussion confidence
timeFrame: up to 12 weeks
measure: Change in decision preparedness
timeFrame: up to 12 weeks
measure: Change in decision empowerment
timeFrame: up to 12 weeks
measure: Discussion satisfaction
timeFrame: up to 12 weeks
measure: Decision satisfaction
timeFrame: up to 12 weeks
measure: Helpfulness
timeFrame: up to 12 weeks
measure: Taxane chemotherapy treatment decision
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel L Hertz
role: PRINCIPAL_INVESTIGATOR
References: