Clinical trial · Interventional
Clinician Decision Support Algorithm for Chemotherapy-Induced Peripheral Neuropathy
Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations
NCT03514680CI-TRIAL-00057142completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIPN Assessment and Management Algorithm | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Period I
- 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.
- type
- EXPERIMENTAL
- label
- Period II
- description
- * 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
- interventionNames
- Behavioral: CIPN Assessment and Management Algorithm
Primary outcomes (1)
- measure
- Clinician Medical Record Abstraction Form
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKnoerl 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
- DERIVEDKnoerl 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