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

NCT07061236 | Completed

• 1 other identifier: AKaraca
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anxiety; Chemotherapy; Cancer; Nurses; Port Catheters

Keywords

Anxiety; Cancer; Chemotherapy; Nurses; Port Catheters

Outcome Measures

Primary Outcomes (1)

• Anxiety (Beck Anxiety Inventory Score)

  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 Outcomes (1)

• Comfort (General Comfort Questionnaire-Short Form Score)

  1 month

Study Arms (2)

5-FU Elastomeric Pump Education Program

EXPERIMENTAL

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

Standard Oncology Education and Care

NO INTERVENTION

Patients will receive standard institutional care without any additional education or training.

Interventions

Elastomeric Pump Education OTHER

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

5-FU Elastomeric Pump Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (2)

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Location

Koç University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (29)

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  RESULT

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  RESULT

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  RESULT

• Chefchaouni AC, Ouedraogo JM, Bechar H, Belahcen MJ, Rahali Y. Retrospective analysis of failures of ambulatory elastomeric pumps containing 5-FU in a hospital pharmacy unit. J Oncol Pharm Pract. 2023 Jan;29(1):125-129. doi: 10.1177/10781552211060290. Epub 2021 Nov 16.

  PMID: 34783287 RESULT

• Can, A., Hintistan, S. (2021). Kemoterapi alan kanser hastalarının konfor düzeylerinin değerlendirilmesi. Bezmialem Science, 9(3), 310-316.

  RESULT

• Burucu R, Turkben Polat H. Spiritual Well-Being Levels and Self-Care Agency of Patients Receiving Chemotherapy With Port Catheter: A Correlational, Descriptive Study. Holist Nurs Pract. 2024 Nov-Dec 01;38(6):331-340. doi: 10.1097/HNP.0000000000000655. Epub 2024 Oct 14.

  PMID: 39422619 RESULT

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  PMID: 3204199 RESULT

• Abe T, Matsuzaka K, Nakayama T, Otsuka M, Sagara A, Sato F, Yumoto T. Impact of air temperature and drug concentration on liquid emission from elastomeric pumps. J Pharm Health Care Sci. 2021 Jan 5;7(1):1. doi: 10.1186/s40780-020-00185-5.

  PMID: 33397508 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was performed due to the nature of the educational intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: Participants are randomly assigned to intervention or control group

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 8, 2025
• Primary Completion: August 11, 2025
• Study Completion: September 8, 2025
• Last Updated: June 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)