CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Informational Intervention, Survey Administration.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
Overview
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
- Other Informational Intervention
Given CIPN DecisionAid - Other Survey Administration
Ancillary studies
Primary outcome measures
- Change in decision preparedness [Time frame: up to 12 weeks]
Secondary outcome measures (9)
- Change in decision preparedness [Time frame: up to 12 weeks]
- Change in awareness [Time frame: up to 12 weeks]
- Change in discussion confidence [Time frame: up to 12 weeks]
- Change in decision preparedness [Time frame: up to 12 weeks]
- Change in decision empowerment [Time frame: up to 12 weeks]
- Discussion satisfaction [Time frame: up to 12 weeks]
- Decision satisfaction [Time frame: up to 12 weeks]
- Helpfulness [Time frame: up to 12 weeks]
- Taxane chemotherapy treatment decision [Time frame: up to 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Michigan Comprehensive Cancer Center — Ann Arbor
Identifiers
NCT: NCT06915168 · HUM00261498 · NCI-2024-10529 · HUM00261498