Breast CarcinomaNCT06915168
CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer
A study testing Informational Intervention and Survey Administration in people with Breast Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Informational Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to read or speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Daniel L. Hertz, 734-763-0015, DLHertz@med.umich.edu
Daniel L. Hertz
About this study
Official title: CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
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.
- Conditions
- Breast Carcinoma
- Being tested
- Informational Intervention, Survey Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Given CIPN DecisionAid
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (CIPN DecisionAid) | Experimental | Patients receive the CIPN DecisionAid on study. Receives: Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decision preparedness
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
Measured: up to 12 weeks
Secondary outcomes (9)
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).
Measured: up to 12 weeks
Change in awareness
Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.
Measured: up to 12 weeks
Change in discussion confidence
Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.
Measured: up to 12 weeks
Change in decision preparedness
Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.
Measured: up to 12 weeks
Change in decision empowerment
Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.
Measured: up to 12 weeks
Discussion satisfaction
Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.
Measured: up to 12 weeks
Decision satisfaction
Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.
Measured: up to 12 weeks
Helpfulness
Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.
Measured: up to 12 weeks
Taxane chemotherapy treatment decision
Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start13 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel L Hertz, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915168
- Sponsor's protocol ID
- HUM00261498
- Other IDs
- NCI-2024-10529, HUM00261498
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
- ClinicalTrials.gov ID
- NCT06915168
- Acronym / sponsor ID
- HUM00261498
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (CIPN DecisionAid) | Experimental | Other: Informational Intervention, Other: Survey AdministrationPatients receive the CIPN DecisionAid on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to read or speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionGiven CIPN DecisionAid | Other | Supportive care (CIPN DecisionAid) |
| Survey AdministrationAncillary studies | Other | Supportive care (CIPN DecisionAid) |
Primary outcome
Change in decision preparedness
Time frame: up to 12 weeks
Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel L Hertz principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention and Survey Administration in people with Breast Carcinoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Hertz (734-763-0015, DLHertz@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decision preparedness (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.