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Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

Primary Purpose

Cancer, Chemotherapy-induced Peripheral Neuropathy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CIPN Assessment and Management Algorithm

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer Care, Chemotherapy-induced peripheral neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Period I

Period II

Arm Description

-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.

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

Outcomes

Primary Outcome Measures

Clinician Medical Record Abstraction Form

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

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03514680

First Posted

April 21, 2018

Last Updated

March 15, 2022

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT03514680

Brief Title

Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 4, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Chemotherapy-induced Peripheral Neuropathy

Keywords

Cancer Care, Chemotherapy-induced peripheral neuropathy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Period I

Arm Type

No Intervention

Arm Description

Arm Title

Period II

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CIPN Assessment and Management Algorithm

Intervention Description

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 Measure Information:

Title

Clinician Medical Record Abstraction Form

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

0 - 10 Worst CIPN Numerical Rating Scale

Description

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

Time Frame

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

Title

Adapted Acceptability E - Scale

Description

Time Frame

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

Title

Feasibility of Algorithm Implementation

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Knoerl, PhD, RN

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34568984

Citation

Knoerl R, Mazzola E, Mitchell SA, Hong F, Salehi E, McCleary N, Ligibel JA, Reyes K, Berry DL. Measurement properties of brief neuropathy screening items in cancer patients receiving taxanes, platinums, or proteasome inhibitors. J Patient Rep Outcomes. 2021 Sep 26;5(1):101. doi: 10.1186/s41687-021-00377-z.

Results Reference

derived

PubMed Identifier

33676431

Citation

Knoerl R, Mazzola E, Hong F, Salehi E, McCleary N, Ligibel J, Reyes K, Berry DL. Exploring the impact of a decision support algorithm to improve clinicians' chemotherapy-induced peripheral neuropathy assessment and management practices: a two-phase, longitudinal study. BMC Cancer. 2021 Mar 6;21(1):236. doi: 10.1186/s12885-021-07965-8.

Results Reference

derived

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Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

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