Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy

NCT03514680 | Completed

• 1 other identifier: 18-049
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy

Keywords

Cancer Care; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Feasibility of Algorithm Implementation

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

Study Arms (2)

Period I

NO INTERVENTION

-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.

Period II

EXPERIMENTAL

* 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

Interventions

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

Period II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• if they are a Medical Doctor, Physician Assistant, or Nurse Practitioner and provide care to oncology patients at one of the study sites
• if they are an adult (18+) who does not have cancer or symptoms of peripheral nerve injury from any cause and speak/read English

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 34568984 DERIVED

• 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.

  PMID: 33676431 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Robert Knoerl, PhD, RN

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 2, 2018
• Study Start: June 4, 2018
• Primary Completion: December 30, 2019
• Study Completion: March 23, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)