Skip to main content
OpenTrials
Completed

NCT Number: NCT03514680

Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Chemotherapy-induced Peripheral Neuropathy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIPN Assessment and Management Algorithm

Behavioral

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

Primary outcomes

  1. 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

  1. European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20): Sensory and Motor Subscales

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

    Change in QLQ-CIPN20 scores between periods. Subscale total scores are scored from 0 - 100, higher scores represent worse neuropathy symptoms.

  2. Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events CIPN Severity and Interference Items

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

    Reliability and validity testing of measure. The severity and interference items are scored from 0 - 4, with higher scores representing worse neuropathy.

  3. 0 - 10 Worst CIPN Numerical Rating Scale

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

    Change in 0 - 10 Worst CIPN Numerical Rating Scale score between periods. Scored from 0 - 10, higher scores represent worse pain.

  4. Adapted Acceptability E - Scale

    Time frame: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.

    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.

  5. Feasibility of Algorithm Implementation

    Time frame: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.

    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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 2, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.