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Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514680
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Cancer Chemotherapy-induced Peripheral Neuropathy Behavioral: CIPN Assessment and Management Algorithm Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Period I
-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
  • 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
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514680


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Robert Knoerl, PhD, RN Dana-Farber Cancer Institute
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Responsible Party: Robert Knoerl, PhD, RN, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03514680    
Other Study ID Numbers: 18-049
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Knoerl, PhD, RN, Dana-Farber Cancer Institute:
Cancer Care
Chemotherapy-induced peripheral neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases