Breast Carcinoma
Conditions
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.
Interventions
OTHERInformational Intervention
Given CIPN DecisionAid
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in decision preparedness | up to 12 weeks | Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in decision preparedness | 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). |
| Change in awareness | up to 12 weeks | Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey. |
| Change in discussion confidence | up to 12 weeks | Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey. |
| Change in decision empowerment | up to 12 weeks | Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey. |
| Discussion satisfaction | up to 12 weeks | Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey. |
| Decision satisfaction | up to 12 weeks | Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey. |
| Helpfulness | up to 12 weeks | Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey. |
| Taxane chemotherapy treatment decision | up to 12 weeks | Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey. |
Countries
United States
Contacts
CONTACTDaniel Hertz
PRINCIPAL_INVESTIGATORDaniel L Hertz
University of Michigan Rogel Cancer Center
Outcome results
None listed