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

NCT06915168 | Recruiting

• 2 other identifiers: HUM00261498NCI-2024-10529
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in decision preparedness

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

  up to 12 weeks

Secondary Outcomes (9)

• Change in decision preparedness

  up to 12 weeks

• Change in awareness

  up to 12 weeks

• Change in discussion confidence

  up to 12 weeks

• Change in decision preparedness

  up to 12 weeks

• Change in decision empowerment

  up to 12 weeks

Study Arms (1)

Supportive care (CIPN DecisionAid)

EXPERIMENTAL

Patients receive the CIPN DecisionAid on study.

Other: Informational Intervention; Other: Survey Administration

Interventions

Informational Intervention OTHER

Given CIPN DecisionAid

Supportive care (CIPN DecisionAid)

Survey Administration OTHER

Ancillary studies

Supportive care (CIPN DecisionAid)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to read or speak English

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel L Hertz

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Hertz

CONTACT

734-763-0015; DLHertz@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 8, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)