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NCT06915168 | RECRUITING | Breast Carcinoma

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

University of Michigan Rogel Cancer Center

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.

Condition or disease

Breast Carcinoma

Intervention/treatment

Informational Intervention

Survey Administration

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : CIPN Decision Aid to Improve Neurotoxic Chemotherapy Decision Making
Actual Study Start Date : 2024-11-13
Estimated Primary Completion Date : 2026-01-31
Estimated Study Completion Date : 2026-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer

Location Details

NCT06915168

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

University of Michigan Comprehensive Cancer Center

Ann Arbor, Road cancer, United States, 48109