The Impact of Neutropenic Precaution Education on Knowledge, Adherence, and Infection Rates in Patients With Cancer: A Pharmacist-Led Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in Patients' Knowledge of Neutropenic Precautions
研究概览
简要总结
The goal of this clinical trial is to test whether pharmacist-led education can improve knowledge and adherence to neutropenic precautions and reduce infection rates in adult cancer patients receiving high-risk chemotherapy. The main questions it aims to answer are:
- Does pharmacist-led education improve patient knowledge of neutropenic fever prevention?
- Does it increase adherence to precautionary behaviors?
- Does it reduce the incidence of febrile neutropenia? Researchers will compare two groups: one receiving standard care and the other receiving additional education by a clinical pharmacist, to assess the impact on patient behavior and infection outcomes.
Participants will:
- Receive either standard care or a structured educational intervention that includes written materials, a counseling session, and an instructional video on neutropenic precautions.
- Complete knowledge and adherence surveys before and after the intervention.
- Be followed for 2-6 months to monitor adherence, infection rates, and treatment outcomes.
详细描述
This randomized, controlled, multi-center clinical trial investigates the effect of a pharmacist-led neutropenic precaution education intervention on knowledge, adherence, and infection outcomes in adult cancer patients undergoing chemotherapy regimens associated with a ≥20% risk of febrile neutropenia.
Initially, the patient's cytotoxic regimen is assessed by the researcher to decide if it is of high risk of febrile neutropenia, using the electronic (iSOFT and HAKEEM) or printed record (paper files) of the patient in the respective department and comparing it to the literature (e.g., NCCN 2026 growth factor guidelines). The patient is directly excluded if they are a pediatric, mentally-incompetent, or if the chemotherapy protocol is not of high risk of febrile neutropenia.
The study targets patients receiving chemotherapy for solid or hematologic malignancies across selected oncology wards in Jordan, because chemotherapy can be of high risk of febrile neutropenia for any type of cancer. These chemotherapy protocols can be taken in outpatient settings (for few hour in an infusion center) or for several days (admission inside a hospital ward).
Randomization is simple randomization via Excel software. 150 patients are randomized separately for each hospital (KAUH and Al-Bashir), so the total number is 300 patients.
Randomization steps:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •You may be able to join this study if all of the following apply to you:
- •You are 18 years or older.
- •You have been diagnosed with any type of cancer (such as breast, colon, lymphoma, etc.).
- •You are currently receiving chemotherapy that has a high risk of lowering your white blood cell count.
- •You are receiving treatment in outpatient (infusion centers) or inpatient settings (oncology wards).
排除标准
- •You cannot join this study if any of the following apply to you:
- •You currently have an active infection (such as fever or diagnosed illness).
- •You are unable to speak Arabic or English, and do not have a caregiver who can help with the study.
- •You have a major psychiatric condition that makes it difficult to understand or participate in the educational activities.
结局指标
主要结局
Change in Patients' Knowledge of Neutropenic Precautions
时间窗: Day 1: Baseline knowledge survey for control and intervention groups, then education session after baseline surveys for intervention group, then knowledge survey redone for intervention group. Day 60: knowledge survey redone for both groups.
Assesses the improvement in knowledge of neutropenia, infection signs, hygiene practices, dietary precautions, and when to seek medical help. The survey contains 14 multiple choice knowledge questions. Measured using a validated knowledge and practice questionnaire constructed by the research team. It was drafted using Mak et al's "Effect of an education program on knowledge, self-care behavior and handwashing competence on prevention of febrile neutropenia among breast cancer patients receiving Doxorubicin and Cyclophosphamide in Chemotherapy Day Centre" with major changes. Then a content validity test was done by 8 PhD holders who are experts in KAP studies and the content validity index relevance was 0.944 and clarity was 0.93. After that an expert panel of 6 oncology clinicians from KAUH assessed the form, and a pilot group of 28 patients all led to form changes. Knowledge part of questionnaire score: 0-14 (the higher, the better is the score)
次要结局
- Change in Adherence to Neutropenic Precautionary Measures(Day 1: Baseline practice survey for control and intervention groups. Day 60: Practice survey redone for both groups.)
- Number of patients who develop Febrile Neutropenia (FN)(Up to 6 months after baseline questionnaire)
- Febrile Neutropenia Curer rates(Up to 6 months after baseline questionnaire.)
- Physician Adherence to Antibiotic Management Guidelines(Up to 6 months after baseline questionnaire.)
- Number of patients with positive bacterial cultures for FN(Up to 6 months after baseline questionnaire.)
- Febrile Neutropenia Treatment Duration(Up to 6 months from baseline questionnaire.)