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.
