Improving 5-Fluorouracil (5-FU) Continuous Infusion Comfort With a New Corset Design in People Affected by Cancer

NCT07317583 | Completed

• 1 other identifier: 2023-19-09
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility randomized controlled trial aims to evaluate the effectiveness and usability of a newly designed supportive corset for patients receiving continuous 5-Fluorouracil (5-FU) infusion therapy. The corset is intended to stabilize the infusion pump and serum set, reduce physical and psychological discomfort, and improve overall quality of life. Forty colorectal cancer patients were randomized into two groups: an intervention group using the corset and a control group receiving standard care. Outcomes include infusion-related experiences (measured by Visual Analog Scale) and quality of life (assessed by EORTC QLQ-C30).

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; 5-Fluorouracil (5-FU)

Outcome Measures

Primary Outcomes (7)

• Physical Restrictions Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Insomnia Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Anxiety During Movement Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Skin Contact Discomfort Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Medication Flow Issues Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Aesthetic Concerns Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

• Nausea Score (Visual Analog Scale)

  Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome.

  4 weeks

Secondary Outcomes (1)

• Quality of Life Score (EORTC QLQ-C30)

  4 weeks

Study Arms (2)

Standard of Care + Supportive Corset

EXPERIMENTAL

Participants receive standard care plus a specially designed supportive corset during continuous 5-FU infusion.

Device: Supportive Corset

Standard of Care

OTHER

Participants receive routine care without any additional intervention.

Other: Standard care

Interventions

Supportive Corset DEVICE

A specially designed supportive corset developed to stabilize the 5-FU infusion pump and serum set during continuous infusion therapy. It includes a body-wrapping belt, adjustable shoulder strap aligned with the port catheter, and a fluid-proof pouch for carrying the infusion pump. The corset aims to enhance comfort, reduce physical and psychological distress, and improve overall treatment experience.

Standard of Care + Supportive Corset

Standard care OTHER

Routine care provided during continuous 5-FU infusion without any additional supportive device.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Diagnosed with colorectal cancer
• Currently receiving chemotherapy
• Having received at least one cycle of 5-FU therapy via continuous infusion
• Volunteering to participate in the study
• Aged 18 years or older

You may not qualify if:

• Diagnosis of brain cancer (excluded due to potential impact on cognitive function and reliability of self-reported data)
• Presence of bone metastases
• Pregnancy and/or lactation
• Communication barriers
• Physician-diagnosed mental illness
• Inability to speak or understand Turkish

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Bakirköy, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gülcan Bağçivan, PHD

  University of Massachusetts Dartmouth, North Dartmouth, United States, Department of Adult Nursing, College of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label; no masking was applied. Both participants and researchers were aware of group assignments because the intervention involved the use of a visible supportive corset during continuous 5-FU infusion therapy.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Specialist

Model Details: This study is a parallel-group, randomized controlled feasibility trial designed to evaluate the effectiveness and usability of a newly developed supportive corset for patients receiving continuous 5-Fluorouracil (5-FU) infusion therapy. Forty colorectal cancer patients were randomly assigned to two groups: an intervention group using the corset in addition to standard care and a control group receiving standard care only. The intervention lasted four weeks, and outcomes were assessed at baseline and post-intervention using the Visual Analog Scale (VAS) for infusion-related experiences and the EORTC QLQ-C30 for quality of life.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 5, 2026
• Study Start: April 10, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)