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

Summary

Cancer is a chronic disease with an increasing global prevalence and high mortality rates. Surgical interventions, radiotherapy, and especially chemotherapy are among the main treatment modalities. Although chemotherapy prolongs survival, it also causes serious physical and psychological side effects. The prolonged and repetitive nature of chemotherapy necessitates safe vascular access, for which port catheters are frequently preferred. These subcutaneously implanted devices reduce the risk of complications and offer significant advantages in outpatient treatment settings.

5-Fluorouracil (5-FU), commonly used in the treatment of metastatic colorectal cancer, requires prolonged intravenous infusion to be effective. In this context, elastomeric pumps (EPs) are portable, user-friendly, non-electronic medical devices that allow for the continuous and controlled administration of 5-FU. EPs enable patients to continue chemotherapy at home, reducing hospital stays and enhancing both patient satisfaction and quality of life. However, environmental factors such as temperature, viscosity, and gravity may cause variations in flow rate, posing potential safety risks. Therefore, nurses must be competent in the use of EPs, patient education, and management of possible complications.

The use of EPs not only affects treatment efficacy but also has a significant impact on the comfort levels and anxiety of cancer patients. Home-based chemotherapy with EPs helps patients cope with uncertainty, fear, and stress associated with the diagnosis and treatment process. Delivering care outside the hospital environment reduces psychological burden and supports the individual's autonomy and social life. Thus, the wider implementation of EPs in 5-FU treatment and the active involvement of nurses in this process contribute substantially to both treatment outcomes and the overall patient experience. This study was designed to evaluate the impact of education provided to chemotherapy patients receiving 5-FU treatment via elastomeric pumps on their comfort and anxiety levels.

Hypotheses:

H1: There is a significant difference in comfort levels between patients educated about 5-FU treatment administered via elastomeric pumps and those receiving standard education.

H2: There is a significant difference in anxiety levels between patients educated about 5-FU treatment administered via elastomeric pumps and those receiving standard education.

H3: Certain variables have a significant effect on the comfort levels of chemotherapy patients receiving 5-FU treatment via elastomeric pumps.

H4: Certain variables have a significant effect on the anxiety levels of chemotherapy patients receiving 5-FU treatment via elastomeric pumps.

The study will be conducted as a randomized controlled trial. At study initiation, participants in both the intervention and control groups will complete the Patient Information Form, General Comfort Questionnaire-Short Form, Beck Anxiety Inventory, and Informed Consent Form during a face-to-face interview. Participants in the intervention group will additionally receive a 15-20 minute training session on the use of the elastomeric pump with 5-FU, based on a patient education booklet developed from current literature, delivered through verbal explanations and visual materials. The control group will follow standard institutional procedures without supplementary training. Follow-up assessments, including the General Comfort Questionnaire-Short Form and Beck Anxiety Inventory, will be re-administered to all participants during face-to-face interviews one month after baseline.

Conditions

• Anxiety
• Comfort
• Chemotherapy
• Education

Interventions

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

Sponsors & Collaborators

• Biruni University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2025-09-30

Completion

2025-09-30

Countries

• Turkey (Türkiye)

Study Locations