University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
NCT Number: NCT06915168
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.
Interested in participating?
Request InfoAll sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Given CIPN DecisionAid
Ancillary studies
Time frame: up to 12 weeks
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
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
Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.
Time frame: up to 12 weeks
Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.
Time frame: up to 12 weeks
Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.
Contact information is provided by the study sponsor or research team.
University of Michigan Rogel Cancer Center
Other
CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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