Pharmacist-Led Education to Improve Neutropenic Precautions in Cancer Patients
The Impact of Neutropenic Precaution Education on Knowledge, Adherence, and Infection Rates in Patients With Cancer: A Pharmacist-Led Intervention
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.
研究概览
详细说明
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:
- In the Excel sheet, the first column was filled as "Intervention" for the first 75 rows and as "control" for the second 75 rows.
- Then a randomization function (rand=) was used for the second column for 150 rows (it gives 150 random numbers with a value between 0 and 1).
- Then both columns were copied and pasted as "paste value" to preserve the sequence of randomization output.
- Then the arrangement of the columns were put in the ascending order (from smaller to larger according to the randomization value of second column), therefore, the intervention/control sequence was changed according to the ascending order of the second column.
- After that, the sheets were protected to prevent any modification to the randomization an a password was added. Thus, the allocation concealment is guaranteed.
- When patients are interviewed, an oral and a written consent are taken first. After consent, the patient is considered as enrolled in the study and they are given a randomization number, and according to the Excel sheet they are treated either as an intervention case or a control case.
- Patients who deny consent do not get a randomization number and are not enrolled as participants. However, they are recorded aside to calculate the response rate of patients.
After enrollment, patients are approached as follows:
At baseline: after consent, both intervention and control patients receive a questionnaire of two parts; a knowledge part consisting of 14 multiple choice questions, and practice part consisting of 25 questions in the 5-point Likert scale (never, rarely, sometimes, usually, often).
Note: Both knowledge and practice parts of the questionnaire went through three validation steps (Content validity assessment by 8 PhD holders in the KAP field, An Expert panel of 6 oncology clinicians in KAUH, and a pilot group of 28 patients feedback). Both parts are concerned with white blood cells and chemotherapy relationship, diet hygiene, body hygiene, hand hygiene, environmental hygiene, dental hygiene, and how to deal with fever with chemotherapy.
- After baseline questionnaire, some demographic information is collected directly from the patients since they may be missing from their hospital records, like martial status, smoking status, performance status, educational level, and family history of cancer. Moreover, nutrition state is judged using the validated PG-SGA short form by direct interview with the patient.
- After the baseline questionnaire, the intervention group receives a structured educational package delivered by the researcher. This includes (1) printed Arabic-translated educational material derived from CDC resources; (2) a face-to-face counseling session explaining neutropenia risks, signs of infection, hygiene practices, dietary precautions, and the importance of early reporting derived from CDC resources; and (3) access to a recorded traceable instructional video derived from CDC resources, the patient is advised and reminded to watch this video twice a week to help memorize the information. On the other hand, the control group receives the current standard of care from the hospital without targeted neutropenic education from the researcher.
- Directly after the educational session is given to the intervention patient, only the knowledge part of the questionnaire is redone to evaluate the robustness of the intervention, and to further anchor the information for the patient.
- After two months from the baseline questionnaire, another face-to-face interview of the patient is done and the knowledge and practice parts are redone. At this point, the change in knowledge and practice will tell if the intervention is significant. Also, both control and intervention groups are asked if they have asked or read about the questionnaire questions after baseline interview, to grasp any confounding increase in knowledge and practice.
- Secondary outcomes like infection rate, antibiotic use, and others, are followed by the electronic records (iSOFT and HAKEEM) of each patient. The follow-up period is intended to observe the patient throughout the whole time of chemotherapy line administration. This follow-up duration is for 6 months (longest duration of a chemotherapy protocol) or 5 weeks after the last chemotherapy dose (the time needed for bone marrow recovery after chemotherapy), whichever is appropriate.
- In addition to patient education, oncologists at participating centers will receive updated clinical guidelines and resources (NCCN 2025, IDSA 2010, and ASCO 2018) on antimicrobial use in febrile neutropenia, including empirical and prophylactic protocols..
This trial will contribute to optimizing the role of clinical pharmacists in oncology, improving patient safety and awareness, and potentially reducing avoidable infections and healthcare burden related to FN in low- and middle-income country settings.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Amman、约旦、11151
- AlBashir Hospital
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Irbid、约旦、22110
- King Abdullah University Hospital (KAUH)
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
-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).
Exclusion Criteria:
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention Group
Participants randomized to this arm will receive a structured pharmacist-led educational intervention aimed at improving their knowledge and adherence to neutropenic precautions. The intervention includes:
|
The Pharmacist-Led Neutropenic Education Package (P-NEP) is a structured educational intervention designed to improve cancer patients' knowledge and adherence to neutropenic fever prevention measures during chemotherapy. It is delivered by a clinical pharmacist and consists of: Written educational materials in Arabic, adapted from the CDC's neutropenia infection prevention guidelines. A face-to-face counseling session that explains neutropenia, signs of infection, hygiene and dietary precautions, and appropriate actions in case of fever. An educational video (shared via URL) reinforcing key messages from the session. Patient support resources, including pharmacist contact information and summary instructions for reference. The intervention is administered prior to chemotherapy and reinforced with a follow-up assessment at 2 months. It is intended to empower patients to implement protective behaviors and report early signs of infection, ultimately aiming to reduce the incidence of FN. |
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无干预：Control Group
Participants in this arm will receive the routine standard care provided in the oncology clinic without the additional structured pharmacist led education. This typically includes general verbal instructions about chemotherapy but no dedicated educational session or materials specific to neutropenic precautions. Knowledge and adherence assessments will be conducted at the same time points as the intervention group to compare outcomes. FN incidence and clinical outcomes will be followed over 6 months. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Patients' Knowledge of Neutropenic Precautions
大体时间：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) |
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.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Adherence to Neutropenic Precautionary Measures
大体时间：Day 1: Baseline practice survey for control and intervention groups. Day 60: Practice survey redone for both groups.
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Evaluates self-reported adherence to infection prevention behaviors (e.g., hand hygiene, mask wearing, dietary precautions, temperature monitoring). The practice survey contains 25 five-point Likert-type questions. It is 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. Practice part of questionnaire score: 25-125 (the higher, the better score) |
Day 1: Baseline practice survey for control and intervention groups. Day 60: Practice survey redone for both groups.
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Number of patients who develop Febrile Neutropenia (FN)
大体时间：Up to 6 months after baseline questionnaire
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Monitors the incidence of febrile neutropenia events among participants over 6 months using clinical and laboratory criteria:
Data are extracted from hospital EMRs (iSOFT, HAKEEM). |
Up to 6 months after baseline questionnaire
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Febrile Neutropenia Curer rates
大体时间：Up to 6 months after baseline questionnaire.
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Assesses the number of patents in which resolution of febrile neutropenia from all patient in which it happened. After febrile neutropenia is treated with antimicrobials, the initial treatment result will be either "infection cure" or will be "treatment failure". Extracted from electronic medical records (iSOFT and HAKEEM). |
Up to 6 months after baseline questionnaire.
|
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Physician Adherence to Antibiotic Management Guidelines
大体时间：Up to 6 months after baseline questionnaire.
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Evaluates oncologist adherence to empiric antibiotic treatment choice for FN based on 2010 IDSA, 2025 NCCN, and 2018 ASCO guidelines. It is assessed by reporting the initial antimicrobial agents used to treat febrile neutropenia from physician notes in the respective hospital (iSOFT and HAKEEM), then it will be compared to the guideline antimicrobial treatment. This outcome will be reported as either "adherent" or "non-adherent". |
Up to 6 months after baseline questionnaire.
|
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Number of patients with positive bacterial cultures for FN
大体时间：Up to 6 months after baseline questionnaire.
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This outcome analyzes the number of patients with positive bacterial cultures from all patients who developed febrile neutropenia. Also, pathogen types and their resistance trends will be recorded. it is collected from laboratory biological culture available on electronic records (iSOFT and HAKEEM). Cultures can be from blood, sputum, urine, wound, etc. Example: Let's say 50 patients developed FN (defined according to ANC and Temperature in the previous outcome description) after the intervention, and 20 of these patients had viable bacterial growth in their biological sample culture, we want to report this percentage (20/50 or 40%). Moreover, we want to categorize the frequency of each pathogen (e.g., From the positive bacterial cultures; 50% of them were Coagulase-negative Staphylococci, 40% were Enterobacteriaceae, 10% were other pathogens). |
Up to 6 months after baseline questionnaire.
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Febrile Neutropenia Treatment Duration
大体时间：Up to 6 months from baseline questionnaire.
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Assesses the time (days) for how long antimicrobials were administered to treat febrile neutropenia until it gets cured or treatment fails.
Extracted from electronic medical records (iSOFT and HAKEEM).
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Up to 6 months from baseline questionnaire.
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合作者和调查者
调查人员
- 首席研究员：Abd Al-Rahman AR Awad, PharmD、Jordan University of Science and Technology
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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