Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT03514680|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Chemotherapy-induced Peripheral Neuropathy||Behavioral: CIPN Assessment and Management Algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study expect to enroll 162 patients, 60 clinicians, and 30 healthy controls for a total of 222.
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|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Robert Knoerl, PhD, RN||617-632-6386||robert_knoerl@DFCI.Harvard.edu|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Robert Knoerl, PhD, RN 617-632-6386 robert_knoerl@DFCI.Harvard.edu|
|Principal Investigator: Robert Knoerl, PhD, RN|
|Principal Investigator:||Robert Knoerl, PhD, RN||Dana-Farber Cancer Institute|