An interventional study of Informational Intervention and Survey Administration in Breast Carcinoma, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive the CIPN DecisionAid on study.
Other: Informational Intervention · Other: Survey Administration
Given CIPN DecisionAid
Ancillary studies
Change in decision preparedness
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Change in decision preparedness
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey. A secondary analysis will be conducted using linear regression adjusting for the treatment (adjuvant versus \[vs\]. metastatic, paclitaxel vs. docetaxel, weekly vs. 3-weekly) and other baseline variables (e.g., age, chemotherapy-induced peripheral neuropathy \[CIPN\] severity).
Time frame: up to 12 weeks
Change in awareness
Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Change in discussion confidence
Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Change in decision preparedness
Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Change in decision empowerment
Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Discussion satisfaction
Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Decision satisfaction
Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Helpfulness
Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Taxane chemotherapy treatment decision
Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University of Michigan Rogel Cancer Center