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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-10529 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00261498 | Other Identifier | University of Michigan Comprehensive Cancer Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (CIPN DecisionAid) | Experimental | Patients receive the CIPN DecisionAid on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Given CIPN DecisionAid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in decision preparedness | Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Hertz | Contact | 734-763-0015 | DLHertz@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel L Hertz | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Survey Administration |
| Other |
Ancillary studies |
|
| up to 12 weeks |
| Change in awareness | Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey. | up to 12 weeks |
| Change in discussion confidence | Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey. | up to 12 weeks |
| Change in decision preparedness | Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey. | up to 12 weeks |
| Change in decision empowerment | Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey. | up to 12 weeks |
| Discussion satisfaction | Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey. | up to 12 weeks |
| Decision satisfaction | Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey. | up to 12 weeks |
| Helpfulness | Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey. | up to 12 weeks |
| Taxane chemotherapy treatment decision | Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey. | up to 12 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |