Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy
- Conditions
- CancerChemotherapy-induced Peripheral Neuropathy
- Interventions
- Behavioral: CIPN Assessment and Management Algorithm
- Registration Number
- NCT03514680
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Period II CIPN Assessment and Management Algorithm * 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
- Primary Outcome Measures
Name Time Method Clinician Medical Record Abstraction Form 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
Name Time Method Feasibility of Algorithm Implementation 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.
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. 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 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 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 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.
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States