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Clinical Trials/NCT03514680
NCT03514680
Completed
Not Applicable

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

Dana-Farber Cancer Institute1 site in 1 country226 target enrollmentJune 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
226
Locations
1
Primary Endpoint
Clinician Medical Record Abstraction Form
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 4, 2018
End Date
March 23, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Knoerl, PhD, RN

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinician Medical Record Abstraction Form

Time Frame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.

Frequency of clinician CIPN assessment and management documentation for each period.

Secondary Outcomes

  • Feasibility of Algorithm Implementation(From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.)
  • European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20): Sensory and Motor Subscales(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(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(From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.)
  • Adapted Acceptability E - Scale(From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.)

Study Sites (1)

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