Impact of Pharmacy Services on Gynaecology Chemotherapy Safety

NCT ID: NCT06826950

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-08

Study Completion Date

2025-01-24

Brief Summary

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What was studied? We wanted to see whether having pharmacists closely involved in cancer care improves medication safety and reduces severe side effects for patients with gynecologic cancers (like ovarian or uterine cancer) during chemotherapy.

How was the study done?

Who participated? Patients receiving chemotherapy at Peking University First Hospital's Gynecologic Oncology Ward (September 2022-September 2024).

Two groups compared:

Standard care group: Pharmacists provided routine pharmaceutical services.

Full pharmacy care group: Pharmacists provided ongoing support, including:

Checking medications for safety.

Teaching patients how to manage side effects.

Answering questions about drugs.

Helping manage reactions like nausea or low white blood cells.

What was measured? Severe side effects (e.g., extreme nausea, appetite loss), how well doctors prescribed and monitored medications to boost white blood cells, and unplanned hospital stays.

Key findings:

Patients with full pharmacy care had:

Fewer severe side effects: Less extreme nausea, appetite loss, and dangerously low white blood cell counts.

Better management of blood cell-boosting medications: Doctors followed guidelines more closely, and patients received proper monitoring.

Fewer unplanned hospital visits: Likely due to better side effect prevention and early intervention.

Why does this matter?

For patients: Pharmacist support during chemotherapy may help you avoid severe side effects and reduce unexpected hospital stays.

For families: Knowing pharmacists are actively involved can provide reassurance about your loved one's medication safety.

For healthcare teams: Structured pharmacist collaboration improves adherence to treatment guidelines and patient outcomes.

Takeaway:

Full pharmacy care throughout chemotherapy helps protect patients' safety, reduces severe reactions, and supports smoother treatment journeys.

Detailed Description

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Conditions

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Neoplasms Gynaecological Oncology

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control group

Routine pharmaceutical services

Intervention Type OTHER

The control group received standard care: After the doctor issues the chemotherapy order, the oncology pharmacist only reviews the order to ensure that the chemotherapy regimen and pretreatment regimen during the study are consistent with those of the experimental group. No other interventions are performed.

Intervention group

comprehensive pharmaceutical care

Intervention Type OTHER

The intervention group received comprehensive pharmaceutical care in addition to standard care. For first-cycle patients, oncology pharmacists conducted patient education, informing them about potential chemotherapy-induced adverse reactions and corresponding management strategies. Patients were instructed on the proper use of antiemetic medications, the recommended frequency of blood routine tests, and the appropriate timing, dosing, and administration of granulocyte colony-stimulating factor (G-CSF) and thrombopoietic agents. A QR code for oncology pharmacist consultation was provided to enable patients to seek advice on medication-related issues encountered outside the hospital.

Interventions

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comprehensive pharmaceutical care

The intervention group received comprehensive pharmaceutical care in addition to standard care. For first-cycle patients, oncology pharmacists conducted patient education, informing them about potential chemotherapy-induced adverse reactions and corresponding management strategies. Patients were instructed on the proper use of antiemetic medications, the recommended frequency of blood routine tests, and the appropriate timing, dosing, and administration of granulocyte colony-stimulating factor (G-CSF) and thrombopoietic agents. A QR code for oncology pharmacist consultation was provided to enable patients to seek advice on medication-related issues encountered outside the hospital.

Intervention Type OTHER

Routine pharmaceutical services

The control group received standard care: After the doctor issues the chemotherapy order, the oncology pharmacist only reviews the order to ensure that the chemotherapy regimen and pretreatment regimen during the study are consistent with those of the experimental group. No other interventions are performed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with gynaecologic malignancies such as ovarian cancer, cervical cancer, endometrial cancer, or gestational trophoblastic tumours.
* Patients who received one of the following chemotherapy regimens: taxane monotherapy or combination therapy, anthracycline monotherapy or combination therapy, platinum-based monotherapy or combination therapy. These chemotherapy regimens could be combined with targeted therapy or immunotherapy.

* Patients who received only targeted therapy, immunotherapy, endocrine therapy, bone-modifying therapy, or combinations of these treatments.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhiqi Zhang

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024SF58

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024Y511-002

Identifier Type: -

Identifier Source: org_study_id

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