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NCT Number: NCT06915168

CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Daniel L. Hertz

CONTACT

[email protected]

734-763-0015

Daniel L. Hertz

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Given CIPN DecisionAid

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Change in decision preparedness

    Time frame: up to 12 weeks

    Will be assessed using Question #2 on the Awareness, Preparedness, and Confidence Survey.

Secondary outcomes

  1. Change in decision preparedness

    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).

  2. Change in awareness

    Time frame: up to 12 weeks

    Will be assessed using Question #1 on the Awareness, Preparedness, and Confidence Survey.

  3. Change in discussion confidence

    Time frame: up to 12 weeks

    Will be assessed using Question #3 on the Awareness, Preparedness, and Confidence Survey.

  4. Change in decision preparedness

    Time frame: up to 12 weeks

    Will be assessed using Question #4 on the Awareness, Preparedness, and Confidence Survey.

  5. Change in decision empowerment

    Time frame: up to 12 weeks

    Will be assessed using Question #5 on the Awareness, Preparedness, and Confidence Survey.

  6. Discussion satisfaction

    Time frame: up to 12 weeks

    Will be assessed using Question #6 on the Satisfaction and Helpfulness Survey.

  7. Decision satisfaction

    Time frame: up to 12 weeks

    Will be assessed using Question #7 on the Satisfaction and Helpfulness Survey.

  8. Helpfulness

    Time frame: up to 12 weeks

    Will be assessed using Question #8 on the Satisfaction and Helpfulness Survey.

  9. Taxane chemotherapy treatment decision

    Time frame: up to 12 weeks

    Will be assessed using Question #9 on the Satisfaction and Helpfulness Survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Hertz

CONTACT

[email protected]

734-763-0015

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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