Evaluating a Clinician Support Algorithm to Enhance Implementation of Evidence-Based Chemotherapy-Induced Peripheral Neuropathy Assessment and Management Recommendations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Clinician Medical Record Abstraction Form
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
Period II
- 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
干预措施: CIPN Assessment and Management Algorithm (Behavioral)
结局指标
主要结局
Clinician Medical Record Abstraction Form
时间窗: 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.
次要结局
- Feasibility of Algorithm Implementation(From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.)
- 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.)
- 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.)
- 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.)
- Adapted Acceptability E - Scale(From enrollment to until all patient participants complete both study periods, assessed up to approximately one year.)
研究者
Robert Knoerl, PhD, RN
Principal Investigator
Dana-Farber Cancer Institute