Clinical trial NCT03514680: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy-induced Peripheral Neuropathy
Keywords: Cancer Care
Chemotherapy-induced peripheral neuropathy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Clinician Medical Record Abstraction Form
timeFrame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.
Secondary outcomes:
measure: European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale (QLQ-CIPN20): Sensory and Motor Subscales
timeFrame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.
measure: Patient-Reported Outcomes National Cancer Institute Common Terminology Criteria for Adverse Events CIPN Severity and Interference Items
timeFrame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.
measure: 0 - 10 Worst CIPN Numerical Rating Scale
timeFrame: From enrollment until the date of the patient's visit 3 time point, assessed up to approximately 10 weeks.
measure: Adapted Acceptability E - Scale
timeFrame: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.
measure: Feasibility of Algorithm Implementation
timeFrame: From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Robert Knoerl, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.