Recruiting

Chemotherapy Decision Aid

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06915168

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Informational Intervention

Survey Administration

Study Details

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

Study ID

NCT06915168

Start date

Nov 13, 2024

Status verified date

Apr, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (CIPN DecisionAid)

Patients receive the CIPN DecisionAid on study.

Interventions

Informational Intervention

Given CIPN DecisionAid

Survey Administration

Ancillary studies

Primary outcome measure

  • Change in decision preparedness [ Time Frame: up to 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Daniel L. Hertz

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-04-08.