Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, 5-Fluorouracil (5-FU)
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).
Detailed description
Continuous infusion of 5-Fluorouracil (5-FU) via portable pumps is a common treatment modality for colorectal cancer, offering clinical benefits such as stable plasma drug levels and improved tolerability. However, patients often experience physical discomfort, restricted mobility, sleep disturbances, anxiety, and aesthetic concerns related to the infusion pump. Technical issues such as unstable connections and medication flow interruptions may further compromise treatment safety. To address these challenges, this study introduces a newly designed supportive corset aimed at stabilizing the infusion pump and serum set during continuous 5-FU therapy. The corset is designed to enhance comfort, reduce movement-related anxiety, and improve sleep quality and overall treatment experience. This feasibility trial enrolled 40 patients diagnosed with colorectal cancer from an outpatient chemotherapy unit in Türkiye. Participants were randomized into two groups: the intervention group received the corset in addition to standard care, while the control group received standard care only. Data were collected at baseline and after four weeks using the Visual Analog Scale (VAS) for infusion-related experiences and the EORTC QLQ-C30 for quality of life. The primary outcomes include changes in physical restrictions, insomnia, anxiety during movement, aesthetic concerns, and overall quality of life. Secondary outcomes include patient satisfaction with the corset. The study was approved by the Clinical Research Ethics Committee (Approval No: 2023-19-09) and conducted in accordance with ethical standards. Findings will inform the feasibility and potential integration of supportive physical devices into cancer care protocols.
Interventions
DEVICESupportive Corset
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.
OTHERStandard care
Routine care provided during continuous 5-FU infusion without any additional supportive device.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Flow Issues Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Aesthetic Concerns Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Nausea Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Physical Restrictions Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Insomnia Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Anxiety During Movement Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
| Skin Contact Discomfort Score (Visual Analog Scale) | 4 weeks | Assessed using Visual Analog Scale (0 = never experienced, 10 = experienced very frequently). Higher scores indicate worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score (EORTC QLQ-C30) | 4 weeks | Assessed using EORTC QLQ-C30 questionnaire (30 items). Functional scales: higher scores = better functioning; symptom scales: higher scores = worse symptoms. Range: 0-100. |
Countries
Turkey (Türkiye)
Outcome results
None listed