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

NCT07061236 | Not Yet Recruiting

• 1 other identifier: AKaraca
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Anxiety, Cancer, Chemotherapy, Nurses, Port Catheters

Outcome Measures

Primary Outcomes (1)

• Anxiety

  The primary outcome measure of this study is the change in anxiety levels, as assessed by the Beck Anxiety Inventory (BAI), from baseline to one month post-intervention. This measure evaluates the effectiveness of the elastomeric pump education on reducing patient anxiety during chemotherapy treatment with 5-FU.

  1 month

Secondary Outcomes (1)

• Change in comfort levels from baseline to one month post-intervention, measured by the General Comfort Questionnaire-Short Form (GCQ-SF).

  1 month

Study Arms (2)

Intervention Group

OTHER

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

Control group

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

Intervention Group

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

Biruni Üniversity

Istanbul, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Anita Karaca, PhD

CONTACT

+90 444 8 276; akaraca@biruni.edu.tr

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 15, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)