Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514680
• Other study ID #: 18-049
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: March 23, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• CIPN Assessment and Management Algorithm
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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.