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

University of Michigan Rogel Cancer Center20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Carcinoma

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in decision preparedness

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

Time frame: up to 12 weeks

Secondary Outcomes

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).

Time frame: up to 12 weeks

Change in awareness

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

Time frame: up to 12 weeks

Change in discussion confidence

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

Time frame: up to 12 weeks

Change in decision preparedness

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

Time frame: up to 12 weeks

Change in decision empowerment

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

Time frame: up to 12 weeks

Discussion satisfaction

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

Time frame: up to 12 weeks

Decision satisfaction

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

Time frame: up to 12 weeks

Helpfulness

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

Time frame: up to 12 weeks

Taxane chemotherapy treatment decision

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

Time frame: up to 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts