Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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This research study is evaluating how well a decision support tool works to improve clinicians' use of recommended chemotherapy-induced peripheral neuropathy (CIPN) assessment and management strategies in participants receiving chemotherapy.

Detailed Description
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This research study will test a new clinician decision support tool for the assessment and management of CIPN. The algorithm is designed to help clinicians make decisions about which strategies to use for the assessment and/or management of CIPN. The investigators need to recruit participants receiving chemotherapy that is known to cause CIPN to determine how well the algorithm works to increase clinicians' use of recommended CIPN assessment and management strategies.

Official Title
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Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations

Conditions
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Cancer, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Behavioral: CIPN Assessment and Management Algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Patients: over 18 years of age, completed one infusion of neurotoxic chemotherapy for the treatment of cancer has at least three more planned clinic visits associated with neurotoxic chemotherapy receipt after the day of consent ambulatory, signed informed consent, willingness to participate in all study activities, speaks/reads English, receives care from one of the clinicians enrolled in the study. Exclusion Criteria for Patients: prognosis of ≤ two months or documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, central nervous system malignancy, vitamin B deficiency, hereditary, nerve compression injury). Inclusion Criteria for Clinicians: -if they are a Medical Doctor, Physician Assistant, or Nurse Practitioner and provide care to oncology patients at one of the study sites Inclusion Criteria for Healthy Controls: -if they are an adult (18+) who does not have cancer or symptoms of peripheral nerve injury from any cause and speak/read English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study expect to enroll 162 patients, 60 clinicians, and 30 healthy controls for a total of 252. 81 patients will be recruited in Period 1 (usual care) and a separate 81 will be recruited in Period 2 (algorithm use). The 60 clinicians will be recruited and will participate in Periods I and II. We will use purposive sampling to recruit 30 health controls to match the age and demographic characteristics of the recruited patients. The healthy controls will receive no intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Period I<br>-Consented patients will complete electronic versions of the PRO-CTCAE CIPN severity and interference items, 0 - 10 worst CIPN pain numerical rating scale, and QLQ-CIPN20 via tablet prior to their clinician visit at the outpatient oncology center at three consecutive clinic visits: baseline, visit 2, visit 3. | |
| Experimental: Period II<br>Consented patients will complete the same battery of assessments from the usual care period at the baseline, visit 2, and visit 3 time points. Following patient completion of the screening questionnaires, study staff will provide the clinicians with a color-coded summary of the patients' responses to the screening questionnaires and the CIPN assessment and management algorithm | Behavioral: CIPN Assessment and Management Algorithm<br>* The revised algorithm incorporates evidence-based CIPN assessment and management strategies and standardized CIPN/pain patient-reported outcomes measures. In terms of processes, trained study staff will administer the screening questionnaires (e.g., PRO-CTCAE, 0 - 10 numerical rating scale of worst CIPN pain intensity) to consented patients before their clinician visit (e.g., in the waiting room). Following patient completion of the screening questionnaires, study staff will provide the clinicians with a color-coded summary of the patients' responses to the screening questionnaires and the CIPN assessment and management algorithm. Clinicians may then use the algorithm at their discretion to guide the assessment and management of their patients' CIPN symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Medical Record Abstraction Form | Frequency of clinician CIPN assessment and management documentation for each period. | From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20): Sensory and Motor Subscales | Change in QLQ-CIPN20 scores between periods. Subscale total scores are scored from 0 - 100, higher scores represent worse neuropathy symptoms. | From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks. | 
| Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events CIPN Severity and Interference Items | Reliability and validity testing of measure. The severity and interference items are scored from 0 - 4, with higher scores representing worse neuropathy. | From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks. | 
| 0 - 10 Worst CIPN Numerical Rating Scale | Change in 0 - 10 Worst CIPN Numerical Rating Scale score between periods. Scored from 0 - 10, higher scores represent worse pain. | From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks. | 
| Adapted Acceptability E - Scale | Mean score will be calculated to determine clinician-related acceptability and satisfaction with intervention use. Each item is scored from 1 - 5, with higher scores representing greater acceptability and satisfaction. | From enrollment to until all patient participants complete both study periods, assessed up to approximately one year. | 
| Feasibility of Algorithm Implementation | Mean score to examine feasibility of intervention feasibility. Each item is scored from 1 - 5, with higher scores representing greater feasibility. Will be completed by clinicians only. | From enrollment to until all patient participants complete both study periods, assessed up to approximately one year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Care, Chemotherapy-induced peripheral neuropathy