NCT07690956

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jul 2025Aug 2026

Study Start

First participant enrolled

July 13, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 6, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Patients' Knowledge of Neutropenic Precautions

    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.

Secondary Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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: * Printed Arabic-translated educational materials based on CDC guidance regarding neutropenic fever precautions. * A one-on-one counseling session delivered by a clinical pharmacist, covering topics such as neutropenia definition, risk factors, hygiene and dietary precautions, early signs of infection, and the importance of prompt medical attention. * A URL to access an educational video that reinforces the same information. * Contact information for support and follow-up. This intervention is delivered before the next chemotherapy session and is reinforced with follow-up at 2 months. Participants' knowledge and adherence will be measured pre-intervention, post-intervention (same session), and at 2 months. They will be followed for 6 months for infection incidence and outcomes.

Other: Pharmacist-Led Neutropenic Education Package

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AlBashir Hospital

Amman, 11151, Jordan

Location

King Abdullah University Hospital (KAUH)

Irbid, 22110, Jordan

Location

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Abd Al-Rahman AR Awad, PharmD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2026

First Posted

July 8, 2026

Study Start

July 13, 2025

Primary Completion

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations