Cancer, Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
Cancer Care, Chemotherapy-induced peripheral neuropathy
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.
Interventions
BEHAVIORALCIPN 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
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed