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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Amman、ヨルダン、11151
- AlBashir Hospital
-
Irbid、ヨルダン、22110
- King Abdullah University Hospital (KAUH)
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patients' Knowledge of Neutropenic Precautions
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Adherence to Neutropenic Precautionary Measures
時間枠：Day 1: Baseline practice survey for control and intervention groups. Day 60: Practice survey redone for both groups.
|
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.
|
|
Number of patients who develop Febrile Neutropenia (FN)
時間枠：Up to 6 months after baseline questionnaire
|
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
|
|
Febrile Neutropenia Curer rates
時間枠：Up to 6 months after baseline questionnaire.
|
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.
|
|
Physician Adherence to Antibiotic Management Guidelines
時間枠：Up to 6 months after baseline questionnaire.
|
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.
|
|
Number of patients with positive bacterial cultures for FN
時間枠：Up to 6 months after baseline questionnaire.
|
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.
|
|
Febrile Neutropenia Treatment Duration
時間枠：Up to 6 months from baseline questionnaire.
|
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).
|
Up to 6 months from baseline questionnaire.
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Abd Al-Rahman AR Awad, PharmD、Jordan University of Science and Technology
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- Mar2025/180-04
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