Education Effect on Comfort and Anxiety in 5-FU Elastomeric Pump Therapy (EDUCAP-5FU)

June 11, 2026 updated by: Anita Karaca, Biruni University

The Effect of Education on Comfort and Anxiety Levels in Patients Receiving 5-FU Treatment Administered With an Elastomeric Pump: A Randomized Controlled Trial

Cancer treatment often requires chemotherapy, which can be administered through portable devices called elastomeric pumps. These pumps allow medications such as 5-fluorouracil (5-FU) to be delivered continuously over an extended period while patients remain at home rather than staying in the hospital. Although this treatment approach offers greater convenience and independence, patients may experience anxiety and uncertainty related to pump use, treatment side effects, and self-care responsibilities.

This study aims to determine whether providing structured education about elastomeric pump use and 5-FU treatment can improve patients' comfort and reduce anxiety. Participants receiving 5-FU chemotherapy through an elastomeric pump will be assigned to either an education group or a standard care group.

Patients in the education group will receive additional training from the researcher using educational materials and a patient information booklet. The training will include information about safe pump use, management of treatment-related symptoms, precautions to take during treatment, and what to do if problems occur. Patients in the standard care group will continue to receive the routine information and care normally provided by the oncology clinic.

Participants will complete questionnaires that measure comfort and anxiety before the study begins and again one month later. The results will help determine whether structured patient education improves the experience of individuals receiving outpatient chemotherapy through elastomeric pumps.

The findings may help healthcare professionals develop more effective educational programs and supportive care strategies for patients receiving home-based chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial aims to evaluate the effect of a structured educational intervention on comfort and anxiety levels among cancer patients receiving 5-fluorouracil (5-FU) chemotherapy through elastomeric pumps in an outpatient setting.

The increasing use of elastomeric pumps has enabled the administration of continuous chemotherapy infusions at home, reducing hospitalization and improving treatment convenience. However, patients may experience anxiety and reduced comfort due to insufficient knowledge regarding pump management, treatment-related side effects, and self-care requirements. Providing standardized education may improve patients' understanding of treatment, enhance self-management, and promote psychological well-being.

Eligible participants receiving 5-FU chemotherapy via elastomeric pump will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a structured education program delivered by the researcher using evidence-based educational materials and a patient information booklet specifically prepared for elastomeric pump management. The educational content will include information on pump use, safety precautions, potential complications, symptom management, and appropriate actions in case of treatment-related problems. Participants in the control group will continue to receive routine care and standard education provided by the outpatient oncology clinic.

Data will be collected at baseline and one month after the intervention. Comfort and anxiety levels will be evaluated using validated measurement tools. Changes in outcomes over time and differences between groups will be examined to determine the effectiveness of the educational intervention.

The findings of this study are expected to contribute to oncology nursing practice by providing evidence regarding the role of patient education in improving comfort and reducing anxiety among patients receiving outpatient chemotherapy through elastomeric pumps.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Koc University Hospital
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey (Türkiye), 34015
        • Biruni University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with cancer,
  • Able to understand Turkish and literate,
  • Medically fit to participate in the study,
  • Willing to participate in the study,
  • Aged 18 years or older.

Exclusion Criteria:

  • Diagnosed with a psychiatric disorder,
  • Unable to communicate effectively,
  • Refusing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-FU Elastomeric Pump Education Program
Patients will receive face-to-face training on the use of the elastomeric pump with 5-FU, supported by an educational booklet.
Other: Elastomeric Pump Education
This intervention involves a 15-20 minute face-to-face training session about the use of the elastomeric pump with 5-FU, supported by visual materials and an educational booklet developed by the researchers based on current literature and expert opinion
No Intervention: Standard Oncology Education and Care
Patients will receive standard institutional care without any additional education or training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety (Beck Anxiety Inventory Score)
Time Frame: 1 month
Change in anxiety level from baseline to one month post-intervention, measured using the Beck Anxiety Inventory. The Beck Anxiety Inventory is a 21-item self-report scale with scores ranging from 0 to 63. Higher scores indicate greater anxiety severity and therefore a worse outcome. Scores of 0-7 indicate minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety, and 26-63 severe anxiety.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort (General Comfort Questionnaire-Short Form Score)
Time Frame: 1 month
Change in comfort levels from baseline to one month post-intervention, measured using the General Comfort Questionnaire-Short Form, a 28-item, six-point Likert-type scale with a total score ranging from 28 to 168. Higher scores indicate greater comfort, while lower scores indicate less comfort.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Actual)

August 11, 2025

Study Completion (Actual)

September 8, 2025

Study Registration Dates

First Submitted

July 2, 2025

First Submitted That Met QC Criteria

July 2, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKaraca (Other Identifier: BiruniU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will only be shared upon reasonable request and subject to approval by the ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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